FDA recall D-1003-2020

Product

Ranitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-322-01; NDC Unit Dose Card: 60687-322-11

Reason for recall

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

Distribution

Nationwide USA

Key facts

Status

Terminated

Initiation date

2019-11-20

Report date

2020-03-18

Termination date

2022-08-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1003-2020