FDAAugust 14, 2018drug

Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per carton, Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV. NDC 51079-947-08

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Failed Impurities/Degradation Specifications; out of specification results for related compound per the manufacturer

What to do

FDA enforcement status: Terminated

Brands named

mylan institutional inc d b a udl laboratoriesmylanmylan institutional

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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