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 Number: D-1253-2020

Firm: Amneal Pharmaceuticals of New York, LLC

Classification: Class II

Status: Terminated

Report Date: 20200506

Initiation Date: 20200415

Termination Date: 20210908

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

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