FDAnews Drug Daily Bulletin
Pharmaceuticals / Quality / Postmarket Safety

Sun Pharma Recalls Over 216,000 Bottles of Blood Pressure, Antidepressant Drugs

Oct. 2, 2015
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Sun Pharma is recalling more than 216,000 bottles of felodipine blood pressure tablets and the antidepressant imipramine because the varnish on labels is leaching a chemical into the containers. The news comes on the heels of a July recall of bupropion hydrochloride tablets made at Sun’s Halol, Gujarat, India, plant.

The products, produced by Sun’s Mutual Pharmaceutical subsidiary, include 187,106 bottles of felodipine extended-release tablets and 29,660 bottles of imipramine.

The problem was detected in stability results, which found trace amounts of benzophenone in the drugs. Sun says the impurity occurs naturally and is unlikely to cause any significant adverse events, and that the recall was initiated as a precaution.

The products were distributed between February 2014 and April of this year. The FDA has designated the recalls Class III, the least worrisome rating.

The July recall of bupropion hydrochloride followed one in March involving eye solutions, continuing a string of recalls of product made at that site. Those recalls followed 2014 recalls by the Halol facility and Detroit-based Caraco Pharmaceutical Laboratories, which distributes drugs for Sun in the U.S.

Sun Pharma did not return a request for comment by press time. — Kellen Owings