FDA recall D-0307-2020

Golden State Medical Supply Inc. · Class II · drug

Product

GSMS: Ranitidine Capsules 150 mg, Rx only, 500 count bottles (NDC 51407-097-05) Manufactured by Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520; Packaged by GSMS, Incorporated, Carmillo, CA 93012 USA.

Reason for recall

CGMP Deviations: Presence of NDMA impurity detected in product.

Distribution

AZ, IA, MA, MO

Key facts

Status: Terminated
Initiation date: 2019-11-06
Report date: 2019-11-20
Termination date: 2021-04-15
Voluntary/Mandated: Voluntary: Firm initiated
Location: Camarillo, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0307-2020