IVAX Pharmaceuticals Issues a Nationwide Recall

IVAX Pharmaceuticals Issues a Nationwide Recall of Goldline Brand Extra Strength Genapap and Extra Strength Genebs

Miami, FL, May 2, 2006 -- IVAX Pharmaceuticals, Inc, Miami, FL, a distributor of Goldline labeled product is initiating a recall of GoldlineTM brand Extra Strength Genapap 500mg (Acetaminophen) Caplets and Tablets and Extra Strength Genebs 500mg (Acetaminophen) Caplets and Tablets. The product lots identified below are being recalled due to a labeling error. Specifically, the product label should indicate that usage should not exceed 8 tablets or caplets in a 24 hour period. The erroneous label indicates not to exceed 12 tablets or caplets in a 24 hour period. In the event the maximum dosage of 8 tablets or caplets in a 24 hour period is exceeded, there may be an increased risk of acetaminophen toxicity to the liver, which may cause adverse health effects. There have been no reports of serious illness or injury relating to this labeling matter.

Consumers who purchased Extra Strength Genapap 500mg Caplets and Tablets or Extra Strength Genebs 500mg Caplets or Tablets with the lot numbers listed below should cease usage and return the product to the location of purchase.

Wholesalers and Retailers should cease distribution and examine their inventory immediately. Return all lots indicated below to the IVAX Distribution Center at the following address;

IVAX Distribution Center 100 Precision Drive Walton, KY 41094 Attn: RECALLED RETURNS

This recall includes the following product and lot numbers;

Product Name

NDC

Strength

Lot

Expiration

Packaging

Extra-Strength Genapap Caplets 0182-2152-01 500mg 5H018D 11/2008 100 count bottles
Extra-Strength Genapap Tablets 0182-1457-01 500mg 5L020B 11/2008 100 count bottles
Extra-Strength Genebs Tablets 0182-1453-10 500mg 5J006A 09/2008 1000 count bottles
Extra-Strength Genebs Tablets 0182-1453-10 500mg 5F001 09/2008 1000 count bottles
Extra-Strength Genebs Tablets 0182-1453-10 500mg 5H007 08/2007 1000 count bottles
Extra-Strength Genebs Tablets 0182-1453-10 500mg 5H007B 08/2008 1000 count bottles
Extra-Strength Genebs Tablets 0182-1453-10 500mg 5L014 11/2008 1000 count bottles
Extra-Strength Genebs Tablets 0182-1453-01 500mg 5L018 11/2008 100 count bottles
Extra-Strength Genebs Tablets 0182-1453-01 500mg 5L019 11/2008 100 count bottles
Extra-Strength Genebs Caplets 0182-1832-01 500mg 5B003 02/2007 100 count bottles
Extra-Strength Genebs Caplets 0182-1832-01 500mg 5F002 06/2007 100 count bottles
Extra-Strength Genebs Caplets 0182-1832-01 500mg 5F004A 06/2007 100 count bottles
Extra-Strength Genebs Caplets 0182-1832-01 500mg 5H003A 08/2008 100 count bottles
Extra-Strength Genebs Caplets 0182-1832-01 500mg 5H005 08/2008 100 count bottles
Extra-Strength Genebs Caplets 0182-1832-01 500mg 5H015 08/2008 100 count bottles
Extra-Strength Genebs Caplets 0182-1832-01 500mg 5H016 08/2008 100 count bottles
Extra-Strength Genebs Caplets 0182-1832-01 500mg 5H018B 11/2008 100 count bottles
Extra-Strength Genebs Caplets 0182-1832-01 500mg 5M024 12/2008 100 count bottles
Extra-Strength Genebs Caplets 0182-1832-01 500mg 5M030A 12/2008 100 count bottles
Extra-Strength Genebs Caplets 0182-1832-01 500mg 6A014 01/2009 100 count bottles
Extra-Strength Genebs Caplets 0182-1832-01 500mg 6B022B 02/2009 100 count bottles
Extra-Strength Genebs Caplets 0182-1832-10 500mg 5B016 02/2007 1000 count bottles
Extra-Strength Genebs Caplets 0182-1832-10 500mg 5F004 06/2007 1000 count bottles
Extra-Strength Genebs Caplets 0182-1832-10 500mg 5F010 06/2007 1000 count bottles
Extra-Strength Genebs Caplets 0182-1832-10 500mg 5F010C 06/2007 1000 count bottles
Extra-Strength Genebs Caplets 0182-1832-10 500mg 5H003 08/2007 1000 count bottles
Extra-Strength Genebs Caplets 0182-1832-10 500mg 5H018A 11/2008 1000 count bottles
Extra-Strength Genebs Caplets 0182-1832-10 500mg 5L009B 12/2008 1000 count bottles
Extra-Strength Genebs Caplets 0182-1832-10 500mg 5M008A 12/2008 1000 count bottles
Extra-Strength Genebs Caplets 0182-1832-10 500mg 5M030 12/2008 1000 count bottles

IVAX Pharmaceuticals is voluntarily recalling the aforementioned lots. All affected inventory is currently on hold. FDA has been apprised of this action.

The tablets/caplets themselves meet product specification, however as stated above the product labeling is incorrect and should indicate not to exceed 8 tablets or caplets in a 24 hour period.

IVAX Pharmaceuticals method of distribution is through direct accounts, which includes wholesalers and retail pharmacies. These products are sold over the counter and have been distributed nationwide and in Puerto Rico.

IVAX is notifying the direct account customers/distributors and direct ship customers who have purchased these products and lots via first class mail recall notification.

Consumers with questions may contact 1-866-262-1243.

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, HF-410, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at http://www.fda.gov/medwatch.

Source: IVAX Pharmaceuticals Issues a Nationwide Recall of Goldline Brand Extra Strength Genapap and Extra Strength Genebs

Posted: May 2006


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