FDAnews Drug Daily Bulletin
Pharmaceuticals / Quality

Sandoz, Macleods Recall Drugs Manufactured in India

March 1, 2016

Manufacturing problems in India continue to cast a shadow, with two drugmakers recalling products from the U.S. market manufactured there.

Sandoz is recalling 277,267 bottles of candesartan cilexetil tablets used to lower blood pressure manufactured by Mylan from the U.S. market, according to an FDA enforcement report.

The Class 3 recall notice was issued due to failed impurities and degradation specifications and stability. A nationwide recall was initiated in December.

Separately, Macleods Pharma is recalling pramipexole dihydrochloride tablets, which are used to treat the signs and symptoms of Parkinson's disease. The ongoing nationwide Class 2 recall is based on the presence of a comingled carbimazole 5 mg tablet, the report states.