Teva recalls generic Prozac made by Croatian subsidiary Pliva

Teva Pharmaceutical Industries' ($TEVA) Croatia-based operating unit Pliva manufactures in Eastern Europe but supplies some of Teva's drugs for the U.S. market. Among those drugs is fluoxetine, a generic version of the antidepressants Sarafem and Prozac, and Teva is having to recall three lots of the product made by Pliva because of contamination.

According to the most recent FDA Enforcement Report, the drugmaker began voluntarily recalling 10-mg and 20-mg bottles of the drug from the U.S. last month after discovering the API in the lots contained an elevated level of a residual solvent impurity. The drugs were manufactured at Pliva's plant in Krakow, Poland.

The Teva Parenteral Medicines unit just last week issued a voluntary recall of 8 lots of its colon and rectal cancer injectable drug Adrucil (fluorouracil injection). That recall came after the drugmaker discovered the lots might contain particulate that Teva said it identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals.

The recalls come as Teva is attempting a $40 billion-plus takeover of unreceptive target Mylan ($MYL). Manufacturing is central to the fight. Teva is touting the cost savings that could come from combining their manufacturing networks while Mylan is pointing to the potential for drug shortages that would come from removing their overlap from the market.

- the recall notices are here and here

Suggested Articles

McCallum was hit with a warning letter from the FDA for testing issues with its products and failing to keep appropriate records.

The FDA made public a voluntary recall of sterile injectables made by Coastal Meds of Mississippi, after visible particles were found in some vials.

It’s been a strange road for BMS' Opdivo-Yervoy combo in first-line kidney cancer, but the New Jersey drugmaker finally has a go-ahead.