FDA recall D-0127-2020

Sandoz, Inc · Class II · drug

Product

Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ Product of India NDC 0781-2855-60

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-0127-2020