FDANovember 22, 2019drug

Ranitidine Tablets, USP 150 mg a).60-count bottles (NDC 65162-253-06) , b).100-count bottles (NDC 65162-253-10), c).180-count bottles (NDC 65162-253-18), d).500-count bottles (NDC 65162-253-50) and e)1000-count bottles (NDC 65162-253-11).

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

The hazard

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

What to do

FDA enforcement status: Ongoing

Brands named

amneal pharmaceuticalsamneal

Recall history

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

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