Teva retrieves amphetamines over impurity concerns

Teva Pharmaceutical ($TEVA) has its hands full already with its $40.5 billion deal to buy Actavis, the generics business of what is now Allergan ($AGN). But business goes on and that includes the occasional recall.

According to the FDA's most recent Enforcement Report, Teva has added another lot, consisting of 9,717 bottles, to a recall of amphetamine tablets that were found to be highly out of spec for impurities during their last testing. The mixed salts product is made up of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate.

According to a letter Teva sent to customers, the voluntary recall began in November with the recall of two lots. It said there are no "safety concerns at the level observed."

Teva CEO Erez Vigodman

The drugmaker had a couple of other significant recalls last year. It recalled three lots of fluoxetine, a generic version of the antidepressants Sarafem and Prozac, because of contamination. Those had been manufactured by its Croatia-based operating unit Pliva at a plant in Krakow, Poland. It also recalled 8 lots of its colon and rectal cancer injectable drug Adrucil (fluorouracil injection) after the drugmaker discovered that the lots might contain particles that it identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals.

The world's largest generics maker struck a deal last year to buy the generics business of Allergan. Teva CEO Erez Vigodman told investors at the J.P. Morgan Healthcare Conference this month that the company's focus this year will be on assimilating the new acquisition into its operations. The buyout comes even as the drugmaker has been significantly reducing its manufacturing operations to cut costs and improve margins.

- here's the recall notice

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