Reported Oct 3, 2012 · Terminated

NAPROXEN TABLETS USP, 500 mg, 100-count Tablets per bottle, Rx only, Manufactured by

Glenmark Generics 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 Generics Inc., USA · 750 Corporate Dr · Mahwah, NJ · 07430-2009

Is this the product you have?

NAPROXEN TABLETS USP, 500 mg, 100-count Tablets per bottle, Rx only, Manufactured by

3 of 3 products

Products covered by this recall
#Product as published
1Glenmark Generics Ltd., Colvale-Bardez, Goa 403513, India
2Manufactured for: Glenmark Generics Inc., USA, Mahwah, NJ 07430
3NDC 68462-190-01.
Lot codes and dates
    • Lot #: 02112930
    • 02112934
    • 02112941
    • Exp 09/14
    • 2112985
    • 02112986
    • 02113334
    • Exp 10/14
    • 02113360
    • 02113372
    • 02113420
    • 02113606
    • 02113663
    • 02113664
    • Exp 11/14
Amount recalled
unknown

Where it was sold

  • Nationwide

Why it was recalled

Labeling: Label Mix-Up: Bottles labeled as Naproxen Tablets USP, 500 mg, 100-count may contain 90-count Pravastatin Sodium Tablets, 40 mg.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Aug 13, 2015 · Data as of Sep 19, 4:59 PM UTC

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