Teva recalls drugs made by India's Emcure over lab testing issues

Teva CEO Erez Vigodman

Teva Pharmaceutical Industries CEO Erez Vigodman has said the company needs to refocus on its generics business. Right now it is focused on recalling about 40,000 bottles of drugs manufactured for it by Emcure Pharmaceuticals in India for deviations in lab testing, an issue the FDA has frequently uncovered at Indian plants.

According to notices in the FDA weekly Enforcement Report, Teva ($TEVA) has been is recalling 22,820 bottles of methlodopa tablets; 13,506 bottles of indomethacin capsules and 2,532 bottles of metformin hydrochloride tablets. All of it was manufactured at Emcure's plant in Hinjawadi in Pune, India, and all of it is being recalled because "laboratory testing was not followed in accordance with GMP requirements."

There are no specifics in the FDA report but agency inspections at Indian manufacturers have routinely uncovered instances where drugmakers will retest failed batches of drugs, report passing test results and delete the failed results out of their computer systems. Just this week the FDA issued a warning letter for a Sun Pharmaceutical plant in Karkhadi in Gujarat, India, that said it uncovered 47 instances of apparent "trial injections" and results deleted from systems. It says at least some of the batches for which out-of–specification (OOS) results were first noted ended up being shipped to the U.S. anyway. The FDA in March banned this plant from shipping products to the U.S.

It seems to be an issue that is prevalent throughout the Indian industry because it was also noted in warning letters the FDA sent to two Wockhardt facilities that it also banned, two Ranbaxy Laboratory plants that its banned and has appeared as a problem in other regulatory actions against Indian facilities, including one operated by Germany's Fresenius Kabi.

The Teva recalls actually began in March, the notice says and are designated as Class II: instances where adverse reactions are possible but considered remote. And it is not as if there are not lots of recalls tied to manufacturing plants in many countries including the U.S. and elsewhere. Teva in April recalled more than 1 million bottles of generics of Eli Lilly's ($LLY) top-selling blockbuster Cymbalta, which it only began shipping in December. All of those were manufactured at a Teva plant in Israel and were being recalled because of a customer complaint about capsule breakage. The company said it found the cause of the problem and has since fixed it.

- here's the FDA recall notice
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