B&G Foods Recall Ortega Taco Seasoning Mix, Ortega Taco Sauce, Ortega Enchilada Sauce and Ortega Taco Kit products and certain Las Palmas Taco Seasoning Mix and Las Palmas Taco Sauce products.

B&G Foods announced today it is voluntarily recalling certain Ortega Taco Seasoning Mix, Ortega Taco Sauce, Ortega Enchilada Sauce and Ortega Taco Kit products and certain Las Palmas Taco Seasoning Mix and Las Palmas Taco Sauce products.

B&G Foods Issues Allergy Alert On Undeclared Peanut And Almond In Product

 

Contact
Consumer:
877-929-2576
www.ortega.com

Media:
Ernest DelBuono
202-973-1318
FOR IMMEDIATE RELEASE – November 14, 2014 – B&G Foods announced today it is voluntarily recalling certain Ortega Taco Seasoning Mix, Ortega Taco Sauce, Ortega Enchilada Sauce and Ortega Taco Kit products and certain Las Palmas Taco Seasoning Mix and Las Palmas Taco Sauce products after learning that one or more of the spice ingredients purchased from a third party supplier contain peanuts and almonds, allergens that are not declared on the products’ ingredient statements. People who have an allergy or severe sensitivity to peanuts and almonds run the risk of serious or life-threatening allergic reaction if they consume these products.  There is no health risk associated with these products for individuals without an allergy to peanuts or almonds.
This recall affects the following products:

Consumer UPC #	Size	Best By Date Range	Description
0 39000 00805 1	10oz	May 18, 2015 - Feb 10, 2016	Ortega Taco Dinner Kit
0 39000 00818 1	16.7oz	May 18, 2015 - Feb 10, 2016	Ortega Taco Dinner Kit
0 39000 00820 4	1.25 oz	Feb 18, 2016 - Nov 3, 2016	Ortega Taco Seasoning
0 39000 00821 1	3.75 oz	Feb 18, 2016 - Nov 3, 2016	Ortega Taco Seasoning  (3 Pack)
0 39000 00860 0	5 lb.	Feb 18, 2016 - Nov 3, 2016	Ortega Taco Meat Seasoning (Foodservice)
0 39000 00861 7	9 oz	Feb 18, 2016 - Nov 3, 2016	Ortega Taco Meat Seasoning (Foodservice)
0 39000 00890 7	8 oz	Feb 18, 2017  -  Nov 10, 2017	Ortega Taco Sauce - Mild
0 39000 00891 4	8 oz	Feb 18, 2017 - Nov 10, 2017	Ortega Taco Sauce - Hot
0 39000 01012 2	15.2oz	May 18, 2015 - Feb 10, 2016	Ortega Soft Taco Dinner Kit
0 39000 01892 0	8 oz	Feb 18, 2017 - Nov 10, 2017	Ortega Taco Sauce - Medium
0 39000 01893 7	16 oz	Feb 18, 2017 - Nov 10, 2017	Ortega Taco Sauce - Mild
0 39000 01894 4	16 oz	Feb 18, 2017 - Nov 10, 2017	Ortega Taco Sauce - Medium
0 41501 00806 5	9.15oz	May 18, 2015 - Feb 10, 2016	Ortega Whole Grain Taco Kit
0 41501 00824 9	1.25oz	Feb 18, 2016-Nov 3, 2016	Ortega 40% Less Sodium Taco Seasoning
0 41501 00832 4	5oz	May 18, 2015 - Feb 10, 2016	Ortega “Tacos for Two” Kit
0 41501 00882 9	144 g	15 MA 18- 16 FE 10	Ortega “Tacos for Two” Kit (Canada)
0 41501 00897 3	8 oz	Feb 18, 2017 - Nov 10, 2017	Ortega Green Taco Sauce - Mild
0 41501 00898 0	8 oz	Feb 18, 2017 - Nov 10, 2017	Ortega Enchilada Sauce
0 41501 00907 9	16 oz	Feb 18, 2017-Nov 10, 2017	Ortega Green Taco Sauce  -  Mild
0 41501 01014 3	13.6 oz	May 18, 2015-Feb 10, 2016	Ortega Whole Wheat Soft Taco Kit
0 41501 01015 0	21.3oz	May 18, 2015 - Feb 10, 2016	Ortega Grande Hard & Soft Taco Dinner Kit
0 41501 01058 7	15.9oz	May 18, 2015-Feb 10, 2016	Ortega Whole Grain/Whole Wheat  Hard & Soft Taco Kit
0 41501 01895 8	16 oz	Feb 18, 2017 - Nov 10, 2017	Ortega Taco Sauce - Hot
0 41501 08351 2	9.8oz	May 18, 2015 - Feb 10, 2016	Ortega Fiesta Flats Kit
0 41501 79811 9	3.75 oz	Feb 18, 2016-Nov 3, 2016	Las Palmas Taco Seasoning Packet (3 Pack)
0 41501 79812 6	106 g	16 FE 18 -  16 NO 03	Las Palmas Taco Seasoning Packets (3 Pack) (Canada)
0 41501 79890 4	8 oz	Feb 18, 2017-Nov 10, 2017	Las Palmas Taco Sauce (Mild)
0 41501 79990 1	226g	17 FE 18 - 17 NO 10	Las Palmas Taco Sauce (Mild) (Canada)
N/A	.33 oz	Feb 18, 2016 - Nov 3, 2016	Ortega Taco Sauce Packets (Foodservice)

The recalled products were distributed in retail stores and foodservice outlets nationwide.
This recall does not apply to any other sizes or varieties of Ortega Seasoning Mix or to any Ortega Seasoning Mixes in canisters, all of which are correctly labeled.  For example, this recall does not include Ortega Fajita Seasoning Mix, Ortega Fish Taco Seasoning Mix, Ortega Chili Seasoning Mix, Ortega Chipotle Seasoning Mix or Ortega Burrito Seasoning Mix, all of which are correctly labeled.  This recall also does not include any Las Palmas Enchilada Sauce, which is correctly labeled.
“The safety of our consumers is our number one priority.  We are committed to providing safe, quality products while observing the highest ethical standards in the conduct of our business,” said William Wright, Executive Vice President of Quality Assurance and R&D at B&G Foods.  “The core values that we’ve embodied since the company was founded in the 1800s — honesty, integrity and accountability — guide our actions as we take the appropriate measures to address this issue.”
This recall was initiated in consultation with the FDA after it was discovered that ingredients from a single supplier used in the affected products were contaminated with peanut and almond allergens. B&G Foods has since terminated its relationship with this supplier and is receiving these ingredients from other sources in anticipation of resuming production shortly.
Consumers who have purchased the recalled products are urged to return them to the place of purchase for a full refund.  Consumers with questions may contact the company’s recall hotline at 877-929-2576 from 8:00 a.m. ET to 8:00 p.m. ET, or visit www.ortega.com for additional information.
About B&G Foods
B&G Foods, Inc. (NYSE: BGS) and its subsidiaries manufacture, sell and distribute a diversified portfolio of high-quality, branded shelf-stable foods across the United States, Canada and Puerto Rico.  Based in Parsippany, New Jersey, B&G Foods’ products are marketed under many recognized brands, including Ac’cent, B&G, B&M, Baker’s Joy, Bear Creek Country Kitchens, Brer Rabbit, Canoleo, Cary’s, Cream of Rice, Cream of Wheat, Devonsheer, Don Pepino, Emeril’s, Grandma’s Molasses, JJ Flats, Joan of Arc, Las Palmas, MacDonald’s, Maple Grove Farms, Molly McButter, Mrs. Dash, New York Flatbreads, New York Style, Old London, Original Tings, Ortega, Pirate’s Booty, Polaner, Red Devil, Regina, Rickland Orchards, Sa‑són, Sclafani, Smart Puffs, Spring Tree, Sugar Twin, Trappey’s, TrueNorth, Underwood, Vermont Maid and Wright’s.  B&G Foods also sells and distributes two branded household products, Static Guard and Kleen Guard.

Great American Appetizers, Inc. of Nampa, Idaho is recalling 662 cases of HyVee Mozzarella Cheese Sticks because they may contain undeclared soy flour, yellow #5 and yellow #6. People who have an allergy or sensitivity to soy, yellow #5 or yellow #6 can run the risk of serious allergic reaction if they consume this product.

The HyVee Mozzarella Sticks were distributed to retailers in Iowa, Illinois, Kansas, Minnesota, Missouri, Nebraska, South Dakota, and Wisconsin.

Great American Appetizers, Inc. Recalls Hyvee Mozzarella Cheese Sticks Due To Undeclared Soy Flour, Yellow #5, And Yellow #6

Contact:
Consumer:
1-800-282-4834
KalaT@appetizer.com

FOR IMMEDIATE RELEASE - November 14, 2014 - Great American Appetizers, Inc. of Nampa, Idaho is recalling 662 cases of HyVee Mozzarella Cheese Sticks because they may contain undeclared soy flour, yellow #5 and yellow #6. People who have an allergy or sensitivity to soy, yellow #5 or yellow #6 can run the risk of serious allergic reaction if they consume this product.

The HyVee Mozzarella Sticks were distributed to retailers in Iowa, Illinois, Kansas, Minnesota, Missouri, Nebraska, South Dakota, and Wisconsin.
The HyVee Mozzarella Cheese Sticks affected are in an 8 oz. (227 g) carton (UPC #075450149913). The product date codes are printed on the end of the carton: 14290402 (BEST IF USED BY 4/17/2016) and 14295402 (BEST IF USED BY 4/22/2016). No other date codes are affected by this recall.
No illnesses have been reported to date.
This incident was discovered in-house by the company’s internal packaging review. Great American Appetizers, Inc. staff determined that the new carton did not accurately describe all allergens present in the product during the packaging update.
This recall is being made with the knowledge of the U.S. Food and Drug Administration.
Consumers who have purchased HyVee Mozzarella Cheese Sticks may return them to the place of purchase for a full refund. Consumers with questions may contact the company at: 1-800-282-4834 from 8AM – 5PM Mountain Time, or email inquiries to KalaT@appetizer.com.

Mayhem Dietary Supplement Recalled By Chaotic Labz.

 FDA laboratory analysis found that Mayhem Dietary Supplement contains undeclared dexamethasone, a prescription corticosteroid commonly used to treat inflammatory conditions, and cyproheptadine, a prescription antihistamine used for seasonal allergy treatment, making this an unapproved drug.

Chaotic Labz Issues Voluntary Nationwide Recall of Mayhem Dietary Supplement Due to Undeclared Dexamethasone and Cyproheptadine

Contact:
Consumer:
Chaotic Labz
1-479-223-2677
FOR IMMEDIATE RELEASE – November 14, 2014 – Chaotic Labz, Atkins, Arkansas, is voluntarily conducting a nationwide recall of Mayhem dietary supplement capsules, Lot #CLM061114 with an expiration date of 06/2016, to the user/consumer level. Mayhem’s intended use is as a bodybuilding supplement. FDA laboratory analysis found that Mayhem Dietary Supplement contains undeclared dexamethasone, a prescription corticosteroid commonly used to treat inflammatory conditions, and cyproheptadine, a prescription antihistamine used for seasonal allergy treatment, making this an unapproved drug.
Consumers are advised that corticosteroid use can impair a person’s ability to fight infections, cause high blood sugar levels, muscle injuries and psychiatric problems. When corticosteroids are taken for a prolonged period, or at high doses, they can suppress the adrenal gland and cause withdrawal symptoms with abrupt discontinuation. Antihistamines may cause drowsiness and affect mental alertness. In addition, these undeclared drug ingredients in Mayhem may cause serious side effects when combined with other medications. To date, Chaotic Labz has not received reports of these adverse effects related to this recall.
Mayhem is packaged in a clear bottle with yellow capsules associated with Lot #CLM061114 with an expiration date of 06/2016. The product can be identified by the brand known as Chaotic Labz and product name Mayhem, Appetite for Construction. This product was distributed nationwide to various Nutritional Supplement Retail Outlets and via the internet.
Chaotic Labz is notifying its distributors and customers by a formal recall notification and arranging for a return of all recalled products. Distribution of Mayhem will also be halted. Consumers, Distributors, and Retailers that have any of the recalled product should STOP USING and return immediately to the place of purchase. Contact your health care professional if you have experienced any adverse effects.
Consumers with questions regarding the recall can contact Cordy Hooten, Owner of Chaotic Labz, by phone number at (479) 223-2677 or email at contact.chaoticlabz@gmail.com, Monday – Friday from 9am-5pm central standard time. No other products distributed by Chaotic Labz are subject to recall.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Philips Healthcare (Children’s Medical Ventures) Recalls All Gel-E Donut / Squishon 2 Products.

Children’s Medical Ventures initiated a recall due to mold contamination of some products, which occurred during the manufacturing process. The mold types detected on the products have been identified as types which are commonly found in indoor and outdoor environments. There is potential for the mold to be transferred to patient environments once the outer pack is opened. There is the possibility of fungal infection should patients come in contact with the mold, which could be superficial or invasive and life threatening.

Philips Healthcare Announces Recall of Children’s Medical Ventures Gel-E Donut / Squishon 2 Products

Contacts
Customers:
Phone: (770) 510-4681 or (770) 510-4684
Media:
Rachel Bloom-Baglin
Email: Rachel.Bloom-Baglin@philips.com
Phone: 978-760-9007
Steve Klink
E-mail: Steve.Klink@philips.com
Phone: +31 6 10888824
FOR IMMEDIATE RELEASE — November 14, 2014 — Andover, MA — Children’s Medical Ventures, a Philips Healthcare business, today announced that the company has issued a recall of all Gel-E Donut gel pillow and Squishon 2 gel cushion products due to potential mold contamination of the products. This action follows a previous recall for these products announced in May 2014. Refer to the table below for a listing of recalled model numbers and quantities, which were manufactured and distributed between July 2012 and August 2014. The model number is printed directly on the product.

Model Number	Quantity Affected
92025-A	96,311
92025-B	109,732
92025-C	50,456
91033-2	80,196
Grand Total	336,695

Customers are being asked to discontinue use and dispose of all Gel-E Donut gel pillow and Squishon 2 gel cushion products in their facility, even if mold is not visible. Following these actions, customers will be asked to return a reply form indicating that these actions have been completed. Customers will be given credit for all products scrapped.
In May 2014, Children’s Medical Ventures initiated a recall due to mold contamination of some products, which occurred during the manufacturing process. The mold types detected on the products have been identified as types which are commonly found in indoor and outdoor environments. There is potential for the mold to be transferred to patient environments once the outer pack is opened. There is the possibility of fungal infection should patients come in contact with the mold, which could be superficial or invasive and life threatening.
At the time of the initial recall, Children’s Medical Ventures implemented a process intended to reduce the presence of viable mold on the products prior to shipment. Since then, Philips has received one new report of the presence of mold on product. Because the process to eliminate the potential for mold growth has not been fully effective, the company is announcing this new recall.
The Children’s Medical Ventures Gel-E Donut gel pillow and Squishon 2 gel cushions are intended to help support an infant’s head or body in a hospital environment. The products are intended to be used in Neonatal Intensive Care Units (NICU), Pediatric Intensive Care Units (PICU), and neonatal care centers.
Countries where affected devices have been shipped include the United States, Australia, Austria, Belgium, Canada, France, Germany, Iceland, Ireland, Italy, Japan, Kuwait, Netherlands, New Zealand, Norway, Portugal, Reunion, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Thailand and United Kingdom.
Customers who have questions about the recall or require further information or support concerning this issue, may contact their local Philips representative at (770) 510-4681 or (770) 510-4684. Distributors outside of the U.S. should contact their local Philips representative.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Organic Raw Almonds Recalled By Whole Foods.

Customers who purchased the Organic Raw Almonds (bitter almonds), at issue in the voluntary recall should discard the products and return to the store with their receipt for a full refund. Please contact 512-477-5566 ext. 20060 with any questions between the hours of 9 am and 5 pm Central Standard Time, Monday through Friday.

Marin Food Specialties, Inc. Initiates Voluntary Recall of Imported Organic Raw Almonds (Bitter Almonds) Due to Elevated Levels of Naturally Occurring Hydrogen Cyanide

Contact:
Consumer:
512-477-5566 ext. 20060
FOR IMMEDIATE RELEASE — November 7, 2014— Marin Foods Specialties, Inc. of Byron, CA is voluntarily recalling Organic Raw Almonds (bitter almonds), due to them possibly containing elevated levels of naturally occurring hydrogen cyanide according to laboratory test results. To date, no human illnesses have been associated with these products and they have been pulled from sale.
Bitter almonds are the wild form of the edible "sweet almonds." Bitter almonds contain a chemical called glycoside amygdalin, which becomes transformed into toxic prussic acid (hydrogen cyanide) after they are crushed or chewed. Eating foods that contain prussic acid may result in some or all of the following signs and clinical symptoms within minutes: dizziness, headache, nausea and vomiting, rapid breathing, rapid heart rate, restlessness, and weakness. Exposure to higher quantities of food containing prussic acid may cause other more serious health effects including convulsions, loss of consciousness, low blood pressure, lung injury, slow heart rate, and respiratory failure leading to death. Showing these signs and symptoms does not necessarily mean that a person has been exposed to cyanide. Treatment with supportive measures and available specific and efficacious antidotes frequently allows survival.
The products were labeled as “Whole Foods Market Organic Raw Almonds Imported from Italy” and “Whole Foods Market Organic Raw Almonds Imported from Spain,” and were packaged in 13.5 oz. plastic tubs. The recalled products have sell-by dates from 4/18/15 to 6/7/15 and a UPC code of UPC 9-99482-00071-7. The recalled product was distributed to Whole Foods Market stores only in Northern California, Oregon, Washington, Reno, Nevada and Boise, Idaho including:
Northern California:

4315 Arden Way	Sacramento	CA	95864
3000 Telegraph Avenue	Berkeley	CA	94705
731 East Blithedale	Mill Valley	CA	94941
1140 Blossom Hill Rd.	San Jose	CA	95118
1690 South Bascom Avenue	Campbell	CA	95008
1710 41st Ave	Capitola	CA	95010
2001 Market Street	San Francisco	CA	94114
390 Coddingtown Mall	Santa Rosa	CA	95401
500 First St	Davis	CA	95616
270 Palladio Pkwy	Folsom	CA	95630
1765 California Street	San Francisco	CA	94109
3111 Mowry Ave	Fremont	CA	94538
650 W. Shaw Ave	Fresno	CA	93704
1025 Gilman Street	Berkeley	CA	94710
690 Stanyan St	San Francisco	CA	94117
230 Bay Place	Oakland	CA	94612
3502 Mt. Diablo Blvd.	Lafayette	CA	94549
4800 El Camino Real	Los Altos	CA	94022
15980 Los Gatos Blvd.	Los Gatos	CA	95032
414 Miller Avenue	Mill Valley	CA	94941
800 Del Monte Center	Monterey	CA	93940
3682 Bel Aire Plaza	Napa	CA	94558
3950 24th Street	San Francisco	CA	94114
790 DeLong Ave	Novato	CA	94945
1150 Ocean Ave	San Francisco	CA	94112
774 Emerson Street	Palo Alto	CA	94301
621 E. Washington Street	Petaluma	CA	94952
450 Rhode Island	San Francisco	CA	94107
1250 Jefferson Ave	Redwood City	CA	94063
1001 Galleria Blvd	Roseville	CA	95678
1010 Park Place	San Mateo	CA	94403
340 Third Street	San Rafael	CA	94901
100 Sunset Drive	San Ramon	CA	94583
911 Soquel Ave.	Santa Cruz	CA	95062
1181 Yulupa Ave.	Santa Rosa	CA	95405
6910 McKinley Street	Sebastopol	CA	95472
399 4th Street	San Francisco	CA	94107
201 West Napa Street #11	Sonoma	CA	95476
20955 Stevens Creek Blvd	Cupertino	CA	95014
1333 E. Newell Ave.	Walnut Creek	CA	94596

Oregon:

2610 NE Hwy 20	Bend	OR	97701
7380 SW Bridgeport Rd	Tigard	OR	97224
3535 NE 15th Ave.	Portland	OR	97212
12220 SW Scholls Ferry Road	Tigard	OR	97223
4301 NE Sandy Blvd	Portland	OR	97213
2825 East Burnside St.	Portland	OR	97214
1210 NW Couch Street	Portland	OR	97209
19440 NW Cornell Rd.	Hillsboro	OR	97124

Washington:

888 116th Ave. NE	Bellevue	WA	98004
2001 15th Ave - West	Seattle	WA	98119
2800 196th St. SW Ste. 100	Lynnwood	WA	98036
815 Southeast 160th Avenue	Vancouver	WA	98683
17991 NE Redmond Way	Redmond	WA	98052
1026 NE 64th Street	Seattle	WA	98115
2210 Westlake Avenue	Seattle	WA	98121

Reno, NV:

6139 South Virginia St

Reno

NV

89502

Boise, ID:

401 S. Broadway St

Boise

ID

83702

Customers who purchased the products at issue in the voluntary recall should discard the products and return to the store with their receipt for a full refund. Please contact 512-477-5566 ext. 20060 with any questions between the hours of 9 am and 5 pm Central Standard Time, Monday through Friday.

FTC Charges Gerber (Nestlé Nutrition) with Falsely Advertising Its Good Start Gentle Formula

FTC has charges Gerber (Nestlé Nutrition) with false advertising related to it's Good Start Gentle formula.

“Parents trusted Gerber to tell the truth about the health benefits of its formula, and the company’s ads failed to live up to that trust,” said Jessica Rich, Director of the FTC’s Bureau of Consumer Protection. “Gerber didn’t have evidence to back up its claim that Good Start Gentle formula reduces the risk of babies developing their parents’ allergies.” In its complaint, the FTC alleges that since 2011, Gerber has advertised its Good Start Gentle formula through advertisements that ran on television, in magazines, at point-of-sale displays, online, and in other promotional material. Good Start Gentle sells for about $24 for a 23.2-ounce package of powdered formula.

Press Release;

Gold badge featured in some Gerber ads stating that Good Start Gentle is the “1st and Only” formula that “Meets FDA Qualified Health Claim.”

Advertising claim that use of Good Start will prevent or reduce the risk of a child developing allergies.

The Federal Trade Commission has charged Gerber Products Co., also doing business as Nestlé Nutrition, with deceptively advertising that feeding its Good Start Gentle formula to infants with a family history of allergies prevents or reduces the risk that they will develop allergies.
The agency also alleges that Gerber has falsely advertised Good Start Gentle’s health claims as FDA-approved. Through its federal court enforcement action, the Commission is seeking to prohibit Gerber from making the alleged false and unsubstantiated allergy-prevention claims.
“Parents trusted Gerber to tell the truth about the health benefits of its formula, and the company’s ads failed to live up to that trust,” said Jessica Rich, Director of the FTC’s Bureau of Consumer Protection. “Gerber didn’t have evidence to back up its claim that Good Start Gentle formula reduces the risk of babies developing their parents’ allergies.”
In its complaint, the FTC alleges that since 2011, Gerber has advertised its Good Start Gentle formula through advertisements that ran on television, in magazines, at point-of-sale displays, online, and in other promotional material. Good Start Gentle sells for about $24 for a 23.2-ounce package of powdered formula.
Good Start Gentle is made with partially hydrolyzed whey proteins (PHWP). Gerber claims that feeding babies this formula, instead of formula made with intact cow’s milk proteins, will prevent or reduce the risk that they will develop allergies. In its ads, Gerber promotes Good Start Gentle by saying, for example:

• “You want your baby to have your imagination…Your smile…Your eyes…Not your allergies.”

Also, a sticker on the package states that Good Start Gentle Formula is the:

• “1^st & ONLY Routine Formula TO REDUCE THE RISK OF DEVELOPING ALLERGIES.”

The agency’s complaint charges that Gerber lacked the scientific substantiation to make these general allergy-prevention claims, in violation of the FTC Act.
In addition, according to the FTC, Gerber’s ads also misrepresent that Good Start Gentle has qualified or received approval for a Food and Drug Administration health claim. For example, some ads prominently featured a gold badge stating that Good Start Gentle is the “1^st and Only” formula that “Meets FDA Qualified Health Claim.”
In 2009, Gerber petitioned the FDA for permission to make a claim connecting PWHP with the reduced risk of one type of allergy, atopic dermatitis, in infants. The FDA allowed Gerber to make the narrow claim but only if Gerber carefully qualified its statement to make it clear that there is “little scientific evidence” for the relationship.
The Commission vote authorizing staff to file the federal court complaint was 5-0. The complaint was filed in the U.S. District Court for the District of New Jersey on October 29, 2014.
NOTE: The Commission files a complaint when it has “reason to believe” that the law has been or is being violated and it appears to the Commission that a proceeding is in the public interest. The case will be decided by the court.
The Federal Trade Commission works for consumers to prevent fraudulent, deceptive, and unfair business practices and to provide information to help spot, stop, and avoid them. To file a complaint in English or Spanish, visit the FTC’s online Complaint Assistant or call 1-877-FTC-HELP (1-877-382-4357). The FTC enters complaints into Consumer Sentinel, a secure, online database available to more than 2,000 civil and criminal law enforcement agencies in the U.S. and abroad. The FTC’s website provides free information on a variety of consumer topics. Like the FTC on Facebook, follow us on Twitter, and subscribe to press releases for the latest FTC news and resources.

Press Release Reference: 

La FTC acusa a Gerber de anunciar falsamente que su fórmula Good Start Gentle protege a los lactantes contra el desarrollo de alergias

Advance Pharmaceutical Recalls Rugby Ferrous Sulfate Tablets

Advance Pharmaceutical Issues Nationwide Voluntary recall of one Lot (# 12G468) of Ferrous Sulfate Tablets, 325 mg, that may actually contain Meclizine HCl 25 mg tablets

Contact:
Consumer:
Advance Pharmaceutical Inc.
Ph: 631-981-4600, Ext. 300
 

FOR IMMEDIATE RELEASE - January 17, 2013 - Advance Pharmaceutical Inc. today announced that it is conducting a voluntary nationwide recall of one lot of Ferrous Sulfate Tablets, 325 mg, Lot 12G468 Exp. 07/14, UPC Barcode 0 0536-5890-01 3. The lot was manufactured and packaged in 100 count bottles by Advance Pharmaceutical Inc. under the label of Rugby NATURAL IRON SUPPLEMENT Ferrous Sulfate. Advance Pharmaceutical Inc. initiated the recall on December 28, 2012 because they received a pharmacist complaint that a bottle of Ferrous Sulfate Tablets, 325 mg 07-2014, contained Meclizine HCl 25 mg tablets, NDC 0536-3990-01. Taking Meclizine HCl 25 mg as Ferrous Sulfate 325 mg may cause serious side effects to those who consume alcohol or other sedatives, those with a pre-existing CNS disorder, those with imprinted kidney or liver function, the elderly, nursing infants of lactating mothers who received the drug and newborns of mothers who received the drug immediately before childbirth.

Consumers who take three tablets daily of the defective product for treatment of iron deficiency will would be inadvertently ingesting 75 mg of meclizine HCl daily, which is close to the maximum daily adult dose in prescription meclizine drug products of 100 mg. Consumption of meclizine three times a day instead of once daily as monograph recommended is likely to lead to significant drug accumulation because it is a long-acting drug with effects that may persist up to 24 hours after a single dose. Meclizine toxicity may lead to dose-related serious adverse events, including impaired alterness, drowsiness, confusion, low blood pressure, coma, and respiratory depression. Without supportive treatment meclizine toxicity has the potential to be life-threatening.

Consumers who have the affected lot may contact Advance Pharmaceutical with questions at 631-981-4600, Ext.300 on Monday through Friday between 8:30 am and 4:30 pm ET.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Online: http://www.fda.gov/MedWatch/report.htm
• Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: http://www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
• Fax: 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

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Photo: Product Labels

Recalled Product Photos Are Also Available on FDA's Flickr Photostream.

Mitosol® (mitomycin for solution) Recalled By Mobius Therapeutics, LLC, FDA

Mobius Therapeutics, LLC Issues a Voluntary Recall of Mitosol® (mitomycin for
solution), 0.2 mg/vial, Kit for Ophthalmic Use

Contact:
Consumer:
1-877-393-6486

Mobius Web Site

FOR IMMEDIATE RELEASE - January 10, 2013 - Mobius Therapeutics, LLC, St. Louis, MO, announced today that it is conducting a voluntary recall of 2 lots of Mitosol® (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use.  The company is taking this voluntary action due to the fact that we cannot exclude the possibility that the affected lots may be non-sterile.  These two lots of Mitosol (mitomycin for solution) Kits may contain a strain of yeast on one or more parts in the kit and should be considered non-sterile and unsafe for use.

Mitosol® (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use is an antimetabolite indicated as an adjunct to ab externo glaucoma surgery. The user level for this product would be physicians in hospitals and clinics during surgery. Use of these potentially contaminated products could result in serious eye problems/infections, including possible blindness. Mobius has not received any report of adverse events related to this recall. Customers with affected product in their possession should stop using the product immediately and contact Mobius at 1-877-393-6486, Option 2, for safe return of the product.

The impacted product is identified below:

NDC #	Lot #	Exp Date	Product Description
49771-002-01	M098260	08/2013	Mitosol® (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use
49771-002-01	M086920	08/2013	Mitosol® (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use

These lots were distributed in the following states:

AL, AR, DE, GA, IL, IN, MA, MD, ME, MI, MN, MO, NC, NJ, NY, OH, PA, TN, VA, & WI
between the dates of 10/22/2012 and 12/14/2012.

Mobius has initiated an investigation to determine the root cause and corrective and preventative actions.

Mobius has contacted all affected customers by phone call, e-mail and written notification and they are arranging for return of unused product and replacing with product from unaffected lots.

Questions may be directed to Mobius by dialing 1-877-EYE-MITO (1-877-393-6486) and pressing option “2”, Monday to Friday, 8:00 am to 5:00 pm CST. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Online: www.fda.gov/medwatch/report.htm
• Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at:
  www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
• Fax: 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Whole Foods Market recalls carrot cake cupcakes for undeclared walnuts in Northern California

Signage is posted in affected Whole Foods Market stores to notify customers of this recall. The necessary corrections have been made for the cupcake six-packs currently for sale. Consumers who have purchased the affected products from Whole Foods Market may return it to the store for a full refund. Consumers with questions should contact their local store.

Whole Foods Market recalls carrot cake cupcakes for undeclared walnuts in Northern California
Contact:Media:
Libba Letton
libba.letton@wholefoods.com
FOR IMMEDIATE RELEASE - May 11, 2012 - Whole Foods Market is recalling its variety cupcake six-packs sold in stores in Northern California because some of the products contain undeclared walnuts. One illness has been reported to date, and people who have allergies to walnuts run the risk of serious or life-threatening allergic reaction if they consume these products.
Whole Foods Market cupcake six-packs sold in Northern California included several flavors of cupcake, including chocolate, red velvet, and vanilla in addition to carrot cake. Only the carrot cake cupcakes contain walnuts. Six-packs that do not contain carrot cake cupcakes are NOT affected by this recall.
The recalled cupcakes were sold at stores in Folsom, Lafayette, Los Altos, Mill Valley, Novato, Palo Alto, San Francisco, San Jose, Santa Rosa and Sonoma.
The cupcake six-packs came in clear, plastic clamshell containers. The recall includes all expiration packed on dates prior to May 10th 2012. Customers who have purchased these products may return them to the store for a full refund.
Signage is posted in affected Whole Foods Market stores to notify customers of this recall.
The necessary corrections have been made for the cupcake six-packs currently for sale.
Consumers who have purchased the affected products from Whole Foods Market may return it to the store for a full refund. Consumers with questions should contact their local store.

Hospira Recalls Hydromorphone Hydrochloride Injection 1 MG/ML, (C-II) 1 ML Fill In 2.5 ML Carpuject

Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-888-912-7093 to arrange for the return of the product. Replacement product from other lots is available. Customers can send their DEA 222 form to Hospira, 1635 Stone Ridge Drive, Stone Mountain, GA 30083 to order replacement product. For medical inquiries, please contact Hospira Medical Communications at 1-800-615-0187. This phone number is available 24 hours a day, seven days a week.

Hospira Announces A Nationwide Voluntary Recall Of One Lot Of Hydromorphone Hydrochloride Injection 1 MG/ML, (C-II) 1 ML Fill In 2.5 ML Carpuject, That May Contain More Than The Intended Fill Volume
Contact:Consumer:
Hospira Medical Communications
1-800-615-0187
Media
(224) 212-2357
FOR IMMEDIATE RELEASE - May 12, 2012 - Hospira, Inc. (NYSE: HSP), announced today it is initiating a voluntary user level recall of one lot of Hydromorphone Injection, USP, 1 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject™, NDC 0409-1283-31, due to two reported complaints of a single Carpuject containing more than the 1 mL labeled fill volume.
Opioid pain medications such as Hydromorphone have life-threatening consequences if overdosed. Those consequences can include respiratory depression (slowed breathing or suspension of breathing), low blood pressure and reduced heart rate including circulatory collapse.
The affected product is a prefilled glass cartridge for use with the Carpuject Syringe system. The affected lot number is 07547LL. The expiration date is July 1, 2013.
The affected lot was distributed in September – October 2011. It was initially distributed to wholesalers and a limited number of hospitals in Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Indiana, Louisiana, Maryland, Massachusetts, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Washington, and Wisconsin. Hospira is undertaking this recall in consideration of the potential for safety issues if the product is administered to patients.
Hospira has not received any reports of adverse events related to this issue for this lot. Hospira has initiated an investigation to determine the root cause and preventive actions. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-888-912-7093 to arrange for the return of the product. Replacement product from other lots is available. Customers can send their DEA 222 form to Hospira, 1635 Stone Ridge Drive, Stone Mountain, GA 30083 to order replacement product.For medical inquiries, please contact Hospira Medical Communications at 1-800-615-0187. This phone number is available 24 hours a day, seven days a week.Any adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Events Program either online, buy regular mail or by fax.

• Online:
  www.fda.gov/medwatch/report.htm

• Regular mail:
use postage-paid, pre-addressed Form FDA3500 available at www.fda.gove/MedWatch/getforms.htm

• Fax:
1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).About HospiraHospira, Inc. is the world's leading provider of injectable drugs and infusion technologies. Through its broad, integrated portfolio, Hospira is uniquely positioned to Advance Wellness™ by improving patient and caregiver safety while reducing healthcare costs. The company is headquartered in Lake Forest, Ill., and has approximately 15,000 employees. Learn more at www.hospira.com