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Tuesday, January 22, 2013

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.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
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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 DateProduct Description
49771-002-01M09826008/2013Mitosol® (mitomycin for solution), 0.2 mg/vial, Kit for
Ophthalmic Use
49771-002-01M08692008/2013Mitosol® (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.