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| Apotex's headquarters in Toronto, Canada--Courtesy of Apotex |
Apotex, the Canadian generics maker that has had years of regulatory run-ins with the FDA, is recalling thousands of bottles of generic Paxil. This time regulators can't point fingers at Apotex. The drugs were manufactured by GlaxoSmithKline ($GSK) and are part of a larger recall for which the FDA spanked GSK.
According to this week's FDA Enforcement Report, Apotex is recalling 25 lots of paroxetine HCL in a variety of doses and formulations because the active pharmaceutical ingredient (API) used in them was contaminated with residual materials and solvents from a waste tank. Apotex did not list the totals for each lot, but one lot of oral suspension contained more than 13,400 bottles.
In April, GSK recalled 47 lots of the antidepressant because of possible contamination in an API manufactured at a plant in Cork, Ireland. The company maintained that the pills posed no risk to human health, but the FDA lambasted the company in a warning letter for concluding the problem was not big enough to give customers a heads-up about the product.
"We are concerned that your firm does not consider the entry of pharmaceutical waste streams into your manufacturing process a significant deviation with a potential quality impact," the regulator said in a warning letter posted on its website.
The recall comes at an interesting time for Apotex, which had the rights from GlaxoSmithKline to market an authorized generic. Mylan ($MYL) had challenged the arrangement in court and won a permanent injunction in July against GSK selling Apotex paroxetine CR. In March, Mylan won a $106.7 million jury award against GSK for breaching an agreement to allow it to sell the authorized generic of Paxil CR.
- the recall notices can be found here
- read the warning letter