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Shaping Beauty, Inc. Issues a Voluntary Nationwide Recall of Weight Loss Pills Found to Contain an Undeclared Drug Ingredient
FOR IMMEDIATE RELEASE- January 24, 2011 - Southampton, PA, Shaping Beauty, Inc. has been informed by the Food and Drug Administration (FDA) that a weight loss dietary supplement sold and marketed by the firm contain an undeclared drug ingredient. FDA lab analyses of dietary supplements distributed by the company were found to contain undeclared Sibutramine used as an appetite suppressant for weight loss. The FDA has not approved the following products as drugs; therefore the safety and effectiveness of this product is unknown. All lots of the following dietary supplement products are being recalled:
CELERITE™ SLIMMING CAPSULES
The products listed above were sold and distributed nationwide via the internet atwww.shapingbeauty.com
FDA advises that these products pose a threat to consumers because Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure,arrhythmias or stroke.
No illnesses or injuries have been reported to the company to date in connection with this product. Shaping Beauty, Inc. has taken this action because it is committed to providing accurate information about its products and because of the concern for the health and safety of consumers. Shaping Beauty, Inc. is working with the FDA in the recall process. It sincerely regrets any inconvenience to customers.
Consumers are advised to return the product to the company’s address in Southampton, PA Consumers with questions may contact Shaping Beauty, Inc. Monday through Friday 9:00 am to 5:30 pm at 1-800-728-2850
Any adverse reactions experienced with the use of this product should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website atwwww.fda.gov/Safety/MedWatch/default.htm2.
American Regent Initiates Nationwide Voluntary Recall of Sodium Thiosulfate Injection, USP 10% (100 mg/mL) 10 mL Single Dose Vials Lot# 0056 Due to Translucent Visible Particles
Walter Tozzi, R.Ph., M.S., M.B.A
Sr. Director of Professional Services
FOR IMMEDIATE RELEASE- February 3, 2011 -American Regent is conducting a nationwide voluntary recall to the consumer and user level of the following product:
Sodium Thiosulfate Injection, USP, 10% (100 mg/mL), 10 mL Single Dose Vial
NDC # 0517-1019-05
Exp Date: January, 2012
PLEASE NOTE: This recall, initiated on February 2, 2011 to the User or Consumer Level, is for lot # 0056 Only. No other lots or sizes of Sodium Thiosulfate Injection, USP are subject to this voluntary recall.
This voluntary recall was initiated because some vials of this lot exhibit translucent visible particles consistent with glass delamination. Glass delamination can occur with high pH solutions when the surface glass from the vial separates into thin layers, resulting in glass particles with a flaky appearance.
Potential adverse events after intravenous administration include damage to blood vessels in the lung, localized swelling, and granuloma formation. American Regent is undertaking this recall in consideration of the potential for safety issues if this lot of product is administered to patients.
Sodium Thiosulfate Injection, USP is indicated in the treatment of cyanide poisoning.
The product was distributed to wholesalers and distributors nationwide.
Hospitals, Emergency Rooms, Infusion Centers, Clinics and other healthcare facilities should not use American Regent Inc., Sodium Thiosulfate Injection, USP, 10% (100mg/mL) 10 mL Single Dose Vial with lot # 0056 for patient care and should immediately quarantine any product for return.
American Regent is notifying its distributors and consumers by email, facsimile and/or overnight courier and is arranging for return of all recalled product. Consumers/distributors/retailers that have product which is being recalled should stop use.
American Regent will credit accounts for all returned product with this lot #. Those with questions about the return or recall process, please call our Customer Service Department at 1-877-788-3232: Monday thru Friday from 8:30AM to 7:00PM ET.
Hospitals, emergency rooms, infusion centers, clinics and healthcare providers, or patients with product quality complaints, medical or other questions concerning the use of the product or reasons for this recall should contact the Professional Services Department at 1-877-788-3232.
Any adverse reactions experienced with the use of this product should be reported to American Regent, Inc. via email firstname.lastname@example.org, by fax to (610) 650-7781 or (610) 650-0170 or by phone at 1-800-734-9236. TO EXPEDITE HANDLING PLEASE DO NOT REPORT ANYTHING OTHER THAN SPECIFIC ADVERSE EVENTS TO THIS EMAIL ADDRESS OR FAX OR PHONE.
“All of us at Luitpold Pharmaceuticals and American Regent are committed to taking the necessary steps to protect patients from any potential safety risks with our Sodium Thiosulfate Injection. The safety of patients receiving our products is our primary concern.” said Mary Jane Helenek, President and CEO of American Regent.
While American Regent continues to investigate this issue, the company is taking precautionary action and initiated this voluntary recall. American Regent has informed the FDA of its actions and is maintaining ongoing discussions with the agency.
As is standard practice, and as stated in the Sodium Thiosulfate Injection, USP Product Package Insert, “Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.”
Sodium Thiosulfate Injection, USP is manufactured by Luitpold Pharmaceuticals, Inc. and is distributed by American Regent, Inc. (Shirley, NY).
Source: Luitpold Pharmaceuticals, Inc.
This voluntary recall is being conducted with the knowledge of the U.S. Food and Drug Administration.