FDA recall D-0631-2020

Product

Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per cup, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio. (a) Case of 50 cups (NDC 60687-260-69) (b) Case of 40 cups (NDC 60687-260-23 (c) Unit Dose Cup (NDC 60687-260-69)

Reason for recall

CGMP Deviations: Presence of NDMA impurity detected in product.

Distribution

Nationwide USA

Key facts

Status

Terminated

Initiation date

2019-11-01

Report date

2020-01-08

Termination date

2022-08-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0631-2020