FDA recall D-0348-2025
Glenmark Pharmaceuticals Inc., USA · Class II · drug
Product
Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufactured for: Glenmark Therapeutics Inc., Distributed by: Amazon. NDC# 72657-129-35
Reason for recall
CGMP Deviations
Distribution
U.S. Nationwide
Key facts
- Status
- Ongoing
- Initiation date
- 2025-03-13
- Report date
- 2025-04-16
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Mahwah, NJ, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0348-2025