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IVAX recall

This article was originally published in The Tan Sheet

Executive Summary

IVAX Pharmaceuticals is issuing a voluntary recall of Goldline Extra Strength Genapap and Extra Strength Genebs (both 500 mg acetaminophen) in caplet and tablet form, FDA announces May 2. The Miami, Fla.-based firm is recalling 30 lots due to a labeling error, according to the agency. The product labels should indicate that usage is not to exceed eight tablets/caplets in a 24-hour period; however, the erroneous label indicates not to exceed 12 tablets/caplets in a 24-hour period. If more than eight tablets/caplets are ingested in a 24-hour period, patients may face an increased risk of acetaminophen toxicity to the liver, FDA notes. Consumers are urged to "cease usage and return the product to the location of purchase." Retailers and wholesalers are encouraged to return all unsold lots to IVAX...

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