Side Effects & Recall Lawsuit

Apotex Drug Recall

Details: Parent Category: Lawsuit News Alerts; Category: Recall Lawsuit

Apotex Drug Recall

Certain Lots of the Apotex drug’s, Apo-Amilzide, Apo-Meloxicam, and Apo-Ranitidine, have been recalled.

Apo-Amilzide 5-50 mg is used to treat symptoms of osteoarthritis and rheumatoid arthritis in adults. Apo-Meloxicam 7.5 mg is used for patients with liver cirrhosis for maintenance therapy. Apo-Ranitidine 75 mg and 150 mg are used to help avoid problems associated with excess acid in the stomach. The recall affects on selected lots of these drugs.

The Three Products are on the Canadian market. Health Canada is conducting inspections in Toronto of Apotex manufacturing facilities. Health Canada is now also continuing with their inspections in Ontario Apotex facilities to determine whether manufacturing standards are being followed and to see if any other products are affected.

Elie Betito, the Apotex director of public government affairs claims that there are no efficacy or safety problems involving the products. Betito said that the company voluntarily launched the recall two weeks ago because of raised questions about processes being followed correctly but he was unable to verify the value or volume of the drugs recalled. Betito referred to it as a smaller number of batches that were produced one or two years ago and stated that the drugs are sold in other countries but have different regulatory requirements and formulations.

Apotex was warned by the FDA in June that the new drugs use could be frozen in the U.S. if they failed to fix the multiple manufacturing breaches found at the Toronto facilities. The FDA also warns that they could ban Apotex drugs from entering the country. Apotex is accused of not properly investigating the failure of the batches of some of the drugs and also being guilty of an unusually high number of reject batches.

Apotex is now working with Health Canada who is auditing the company for the next two to three weeks.

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