Class II
Terminated
GSMS Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 60429-641-30), (b) 90-count bottle (NDC 60429-641-90), Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Marketed by: GSMS Incorporated Camarillo, CA 93012 USA.
This recall has been terminated (originally issued November 28, 2018).
- Company
- Sciegen Pharmaceuticals Inc
- Recall Initiated
- October 29, 2018
- Posted
- November 28, 2018
- Recall Number
- D-0271-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 18,760 HDPE bottles
- Firm Location
- Hauppauge, NY, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Distribution
Nationwide
Lot / Code Info
60429-641-90 Irbesartan 150mg Tablets, 90 Count Bottle B161003 Sep-19 B161004 Sep-19 B161006 Sep-19 B161007 Sep-19 B161008 Nov-19 B161009 Nov-19 B161010 Nov-19 C161001 Feb-20 C161003 May-20 60429-641-30 Irbesartan 150mg Tablets, 30 Count Bottle GS019526 Nov-19 GS020252 Nov-19 GS020958 Nov-19
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