Reported Nov 28, 2018 · Terminated
IRBESARTAN Tablets, USP 75 mg 90-count bottle, Rx Only, Manufactured by: SciGen Pharmaceuticals, Inc. Hauppauge, NY…
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 75 mg 90-count bottle, Rx Only
- Manufactured bySciGen Pharmaceuticals, Inc. Hauppauge, NY 11788
- Distributed byGSMS, Incorporated, Camarillo, CA 93012, USA, NDC 60429-640-90
- Lot codes and dates
- Lot Numbers
B160003Exp. 09/19 B160004Exp. 09/19
- Lot Numbers
- Amount recalled
- 2,439 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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