Glenmark Naproxen Sodium 550 mg Tablets Recalled for CGMP Deviations
Glenmark Pharmaceuticals is recalling specific lots of Naproxen Sodium 550 mg tablets nationwide due to manufacturing deviations. The firm initiated the voluntary recall on August 27, 2021.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall for manufacturing deviations with no reported illnesses or injuries, making it a precautionary recall. Per the rubric, manufacturing/labeling issues without reported harm typically fall in the Moderate range.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Naproxen Sodium Tablets, USP 550 mg (prescription only) due to current Good Manufacturing Practice (CGMP) deviations. The affected product was manufactured by Glenmark Pharmaceuticals Inc., USA at locations in Monroe, NC and distributed nationwide.
The recall affects two package sizes: 100-tablet bottles (NDC 68462-179-01, 31,248 bottles) and 500-tablet bottles (NDC 68462-179-05, 300 bottles). Specific lot numbers and expiration dates are available in the FDA recall notice, with expirations ranging from September 2021 through February 2022.
This is a Class II recall initiated voluntarily by the firm through letter notification on August 27, 2021. Consumers who have been prescribed this medication should contact their healthcare provider or pharmacist for guidance. The recall was terminated on October 4, 2023.
The recalled product
- Product
- NAPROXEN SODIUM (NAPROXEN SODIUM)
- Brand
- NAPROXEN SODIUM
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Hazard
- cgmp-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- 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
UPCs (5)
- 0368462189016
- 0368462178010
- 0368462179017
- 0368462188019
- 0368462190012
Distribution
Distributed nationwide across the United States.
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