Glenmark Pharmaceuticals Inc., USA: Naproxen Sodium Tablets, USP 550 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharm

Is my product affected?

Naproxen Sodium Tablets, USP 550 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 100 Tablets NDC 68462-179-01; b) 500 Tablets NDC 68462-179-05

• Brand NAPROXEN SODIUM

Check against the official notice below — it lists the full affected range.

What happened

Glenmark Pharmaceuticals Inc., USA is recalling Naproxen Sodium Tablets, USP 550 mg (prescription only) distributed nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 31,548 bottles across multiple lots with expiration dates ranging from September 2021 through February 2022.

The recalled lots are: 29190082, 29190083, 29190084, 29190085, 29200001, 29200003, 29200004, 29200005, 29200010, 29200012, and 29200013. The source document does not specify a remedy or recommended action for consumers who may have this product.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

CGMP Deviations

Details from the source

Reason for recall: CGMP Deviations Distribution: Nationwide. Quantity: a) 31248 bottles; b) 300 bottles Lot/code info: Lots: a) 29190082 Exp. 09/30/2021; 29190083 Exp. 09/30/2021; 29190084 Exp. 10/31/2021; 29190085 Exp. 10/31/2021; 29200001 Exp. 12/31/2021; 29200003 Exp. 01/31/2022; 29200004 Exp. 01/31/2022; 29200005 Exp. 01/31/2022; 29200012 Exp. 02/28/2022; 29200013 Exp. 02/28/2022; b) 29200010 Exp. 02/28/2022

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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