Nizatidine Oral Solution recalled over manufacturing violations

Recall date

April 15, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Amneal Pharmaceuticals of New York, LLC recalls Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) USP 480 mL bottles, Rx Only Distributed by: Gemini Laboratories, LLC Bri…

Recall number

D-1253-2020

FDA classification

Class II

Brand / firm

Amneal Pharmaceuticals of New York, LLC

Sold / distributed

Nationwide

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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