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Recall Observatory FDA recall evidence

Drug product

NAPROXEN TABLETS USP, 500 mg, 100-count Tablets per bottle, Rx only, Manufactured by: Glenmark Generics Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Generics Inc., USA, Mahwah, NJ 07430; NDC 68462-190-01.

D-1701-2012

July 06, 2012

Class II

Product summary

Firm
Glenmark Generics Inc., USA
Event
Event 63264
Status
Terminated
Classification
Class II
Quantity
unknown
Official record key
drug-enforcement:D-1701-2012

Official wording

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

Code information: Lot #: 02112930, 02112934, 02112941, Exp 09/14; 2112985, 02112986, 02113334, Exp 10/14; 02113360, 02113372, 02113420, 02113606, 02113663, 02113664, Exp 11/14.

Distribution pattern: Nationwide

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Label Mix-Up