Reported Sep 29, 2021 · Terminated
Naproxen Sodium Tablets, USP 550 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road…
Glenmark Pharmaceuticals Inc., USA
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: Glenmark Pharmaceuticals Inc., USA · 750 Corporate Dr · Mahwah, NJ · 07430-2009
Is this the product you have?
- Naproxen Sodium Tablets
- USP 550 mg Rx Only Manufactured byGlenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe
- NC 28110 Manufactured forGlenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 100 Tablets NDC 68462-179-01; b) 500 Tablets NDC 68462-179-05
- Lot codes and dates
- Lots
a) 29190082 Exp. 09/30/202129190083 Exp. 09/30/202129190084 Exp. 10/31/202129190085 Exp. 10/31/202129200001 Exp. 12/31/202129200003 Exp. 01/31/202229200004 Exp. 01/31/202229200005 Exp. 01/31/202229200012 Exp. 02/28/202229200013 Exp. 02/28/2022b) 29200010 Exp. 02/28/2022
- Lots
- Amount recalled
- a) 31248 bottles; b) 300 bottles
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations
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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