FDA recall D-1253-2020

Amneal Pharmaceuticals of New York, LLC · Class II · drug

Product

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

Reason for recall

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

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2020-04-15
Report date: 2020-05-06
Termination date: 2021-09-08
Voluntary/Mandated: Voluntary: Firm initiated
Location: Brookhaven, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1253-2020