FDA recall D-0129-2020

Sandoz, Inc · Class II · drug

Product

Sandoz Ranitidine Hydrochloride Capsules 300mg 30 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Product of India NDC 0781-2865-31

Reason for recall

CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).

Distribution

U.S. Nationwide

Key facts

Status
Terminated
Initiation date
2019-09-23
Report date
2019-10-16
Termination date
2023-07-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0129-2020