FDA recall D-0216-2025

Glenmark Pharmaceuticals Inc., USA · Class II · drug

Product

Carvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05; b) 100 Tablets, NDC 68462-164-01, Manufactured for Glenmark Pharmaceuticals, NJ.

Reason for recall

CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.

Distribution

Nationwide in the U.S

Key facts

Status: Ongoing
Initiation date: 2025-01-22
Report date: 2025-02-12
Voluntary/Mandated: Voluntary: Firm initiated
Location: Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0216-2025