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IVAX Pharmaceuticals Issues a Nationwide Recall of Goldline Brand Extra Strength Genapap and Extra Strength GenebsDate: 5/4/2006
Reason: The product label should indicate that usage should not exceed 8 tablets or caplets in a 24 hour period.
Distribution: Nationwide.
The Food and Drug Administration (FDA) released the following information: 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 This recall includes the following product and lot numbers;
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. Other Drugs / Medicines Recalls and Alerts of InterestDate: 6/12/2008 Reason: Oversized tablets may contain as much as two times the labeled level of active morphine sulfate Date: 6/12/2008 Reason: Limited lots of Atrium heparin-coated Hydraglide Thoracic Catheters were manufactured with heparin found to have been contaminated with oversulfated chondroitin sulfate (OSCS) Distribution: Nationwide Date: 6/12/2008 Reason: it contained a potentially harmful undeclared ingredient, hydroxyhomosildenafil Distribution: Nationwide Date: 6/12/2008 Reason: Limited lots of Carmeda-coated products were manufactured with heparin found to have been contaminated with oversulfated chondroitin sulfate (OSCS). Distribution: Nationwide Date: 6/12/2008 Reason: Taking AZASAN® instead of SOLODYN® presents a health hazard and safety risk to patients Date: 6/16/2008 Reason: Oversized tablets may contain as much as two times the labeled level of active morphine sulfate Distribution: Nationwide |
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