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FDAApril 15, 2020drug

Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) USP 480 mL bottles, Rx Only Distributed by: Gemini Laboratories, LLC Bridgewater, NJ 08807 NDC 60846-301-15

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

The hazard

CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.

What to do

FDA enforcement status: Terminated

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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Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) USP 480 mL bottles, Rx Only Distributed by: Gemini Laboratories, LLC Bridgewater, NJ 08807 NDC 60846-301-15 — Recall Details · AllClear