Reported Nov 28, 2018 · Terminated
GSMS Irbesartan Tablets, USP, 300 mg,(a) 30-count bottle (NDC 60429-642-30), (b) 90-count bottle (NDC 60429-642-90), Rx…
Sciegen Pharmaceuticals 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: Sciegen Pharmaceuticals Inc · 89 Arkay Dr · Hauppauge, NY · 11788-3727
Is this the product you have?
- GSMS Irbesartan Tablets, USP, 300 mg,(a) 30-count bottle (NDC 60429-642-30), (b) 90-count bottle (NDC 60429-642-90), Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788
- Marketed byGSMS Incorporated Camarillo, CA 93012 USA
- Lot codes and dates
- 60429-642-30 Irbesartan 300mg Tablets, 30 Count BottleIrbesartan 300mg Tablets, 90 Count Bottle
GS019036Sep-19GS019073Sep-19GS021472Nov-19GS021530Nov-19GS022234Feb-2060429-642-90
B162009Sep-19B162010Sep-19B162011Sep-19B162012Nov-19B162013Nov-19B162014Nov-19B162015Nov-19C162001Feb-20
- 60429-642-30 Irbesartan 300mg Tablets, 30 Count Bottle
- Amount recalled
- 30,194 HDPE bottles
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (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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