FDA recall D-0753-2022

Sandoz, Inc · Class II · drug

Product

Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc., Princeton, NJ 08540 NDC 0185-0022-01.

Reason for recall

CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2022-03-21
Report date: 2022-04-13
Termination date: 2023-08-14
Voluntary/Mandated: Voluntary: Firm initiated
Location: Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0753-2022