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Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

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

Contact:
IVAX Pharmaceuticals, Inc.
1-866-262-1243

FOR IMMEDIATE RELEASE -- Miami, FL -- May 2, 2006 -- IVAX Pharmaceuticals, Inc, Miami, FL, a distributor of Goldline labeled product is initiating a recall of Goldline™ 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 Caplets0182-2152-01500mg5H018D11/2008100 count bottles
Extra-Strength Genapap Tablets0182-1457-01500mg5L020B11/2008100 count bottles
Extra-Strength Genebs Tablets0182-1453-10500mg5J006A09/20081000 count bottles
Extra-Strength Genebs Tablets0182-1453-10500mg5F00109/20081000 count bottles
Extra-Strength Genebs Tablets0182-1453-10500mg5H00708/20071000 count bottles
Extra-Strength Genebs Tablets0182-1453-10500mg5H007B08/20081000 count bottles
Extra-Strength Genebs Tablets0182-1453-10500mg5L01411/20081000 count bottles
Extra-Strength Genebs Tablets0182-1453-01500mg5L01811/2008100 count bottles
Extra-Strength Genebs Tablets0182-1453-01500mg5L01911/2008100 count bottles
Extra-Strength Genebs Caplets0182-1832-01500mg5B00302/2007100 count bottles
Extra-Strength Genebs Caplets0182-1832-01500mg5F00206/2007100 count bottles
Extra-Strength Genebs Caplets0182-1832-01500mg5F004A06/2007100 count bottles
Extra-Strength Genebs Caplets0182-1832-01500mg5H003A08/2008100 count bottles
Extra-Strength Genebs Caplets0182-1832-01500mg5H00508/2008100 count bottles
Extra-Strength Genebs Caplets0182-1832-01500mg5H01508/2008100 count bottles
Extra-Strength Genebs Caplets0182-1832-01500mg5H01608/2008100 count bottles
Extra-Strength Genebs Caplets0182-1832-01500mg5H018B11/2008100 count bottles
Extra-Strength Genebs Caplets0182-1832-01500mg5M02412/2008100 count bottles
Extra-Strength Genebs Caplets0182-1832-01500mg5M030A12/2008100 count bottles
Extra-Strength Genebs Caplets0182-1832-01500mg6A01401/2009100 count bottles
Extra-Strength Genebs Caplets0182-1832-01500mg6B022B02/2009100 count bottles
Extra-Strength Genebs Caplets0182-1832-10500mg5B01602/20071000 count bottles
Extra-Strength Genebs Caplets0182-1832-10500mg5F00406/20071000 count bottles
Extra-Strength Genebs Caplets0182-1832-10500mg5F01006/20071000 count bottles
Extra-Strength Genebs Caplets0182-1832-10500mg5F010C06/20071000 count bottles
Extra-Strength Genebs Caplets0182-1832-10500mg5H00308/20071000 count bottles
Extra-Strength Genebs Caplets0182-1832-10500mg5H018A11/20081000 count bottles
Extra-Strength Genebs Caplets0182-1832-10500mg5L009B12/20081000 count bottles
Extra-Strength Genebs Caplets0182-1832-10500mg5M008A12/20081000 count bottles
Extra-Strength Genebs Caplets0182-1832-10500mg5M03012/20081000 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.

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