FDA cites manufacturing violations in warning letter to Wyeth
By Elizabeth Rhein
Published on June 02, 2006
The letter, dated May 3, notifies Wyeth of violations at the Puerto Rico plant used to manufacture such drugs as Advil, birth control pill Triphasil, antidepressant Effexor, and hormone replacement drug Prempro.
The violations include failure to maintain clean packing equipment and failure to investigate previous reports of contamination in a timely manner.
A Wyeth spokesperson has issued a statement that the company is working on fixing the problems outlined in the FDA's letter, and that none of the manufacturing problems would have a negative effect on the drugs made at the plant.
As an apparent concession to the FDA, however, the company voluntarily recalled 20 lots of birth control pill Triphasil from wholesale distributors.
No public consumer recall is currently planned, even though the FDA's letter showed concern that affected lots were still on the shelves and that Wyeth had delayed investigation of the situation.
If you are currently taking any of the drugs mentioned and are concerned about their safety, talk to your doctor to determine the best course of action.
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