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FDAJanuary 7, 2020drug

Nizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5150-91.

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

The hazard

CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.

What to do

FDA enforcement status: Terminated

Brands named

mylan pharmaceuticalsmylan

Recall history

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

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Nizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5150-91. — Recall Details · AllClear