Reported Nov 28, 2018 · Terminated
IRBESARTAN Tablets, USP 300 mg (a) 30-count bottle (NDC 60429-642-30), (b) 90-count bottle (NDC 60429-642-90) Rx Only,…
Golden State Medical Supply Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Golden State Medical Supply Inc. · 5187 Camino Ruiz · Camarillo, CA · 93012-8601
Is this the product you have?
- IRBESARTAN Tablets, USP 300 mg (a) 30-count bottle (NDC 60429-642-30), (b) 90-count bottle (NDC 60429-642-90) Rx Only
- Manufactured bySciGen Pharmaceuticals, Inc. Hauppauge, NY 11788
- Distributed byGSMS, Incorporated, Camarillo, CA 93012, USA
- Lot codes and dates
14 of 14 products
Products covered by this recall # Product as published 1 30-count bottles GS019036 2 Exp 09/19 GS019073 3 Exp. 09/19 GS021472 4 Exp. 11/19 GS021530 5 Exp. 11/19 GS022234 6 Exp. 02/20 90-count bottles B162009 7 Exp. 09/19 B162010 8 Exp. 09/19 B162011 9 Exp. 09/19 B162012 10 Exp. 11/19 B162013 11 Exp. 11/19 B162014 12 Exp. 11/19 B162015 13 Exp. 11/19 C162001 14 Exp. 02/20 - Amount recalled
- 12,502 bottles
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Why it was recalled
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product.
This product could cause temporary or reversible health problems — stop using it.
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