Glenmark Recalls Naproxen Sodium Tablets Due to Labeling Error
Glenmark Generics is recalling Naproxen Sodium 500 mg tablets because some bottles may contain Pravastatin Sodium 40 mg tablets.
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: The recall is classified as FDA Class II, which typically involves a temporary or medically reversible adverse health consequence. The hazard is a labeling mix-up resulting in the wrong medication, which fits the criteria for moderate severity involving minor labeling errors or low-risk contamination without reported serious injury.
Plain-English summary
Glenmark Generics Inc., USA is recalling Naproxen Sodium tablets, 500 mg, 100-count, prescription only. The recall is due to a labeling error where bottles labeled as Naproxen Sodium may actually contain Pravastatin Sodium tablets, 40 mg, 90-count.
The affected product is manufactured by Glenmark Generics Ltd. in India for Glenmark Generics Inc. in the USA. The recall covers specific lots with expiration dates ranging from September 2014 to November 2014. The distribution pattern is nationwide.
Consumers should check their medication bottles for the specific lot numbers and expiration dates listed in the recall notice. If the product matches the description, patients should contact their healthcare provider or pharmacist for guidance on discontinuing use and obtaining the correct medication.
The recalled product
- Product
- NAPROXEN SODIUM (NAPROXEN SODIUM)
- Brand
- NAPROXEN SODIUM
- Manufacturer
- Glenmark Generics Inc., USA
- Category
- Drug — Prescription Medication
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 (15)
- Lot #: 02112930
- 02112934
- 02112941
- Exp 09/14
- 2112985
- 02112986
- 02113334
- Exp 10/14
- 02113360
- 02113372
- 02113420
- 02113606
- 02113663
- 02113664
- Exp 11/14.
UPCs (5)
- 0368462189016
- 0368462178010
- 0368462179017
- 0368462188019
- 0368462190012
Distribution
Distributed nationwide across the United States.
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