The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1701-2012·Announced 2012-10-03

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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
Hazard

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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