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Recall Observatory FDA recall evidence

Drug product

Meloxicam Tablets, USP, 15 mg, Rx Only, 100 Tablets per Bottle, Manufactured by: Strides Acrolab Ltd., Bangalore-560 076, India, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-3579-1.

D-1443-2012

April 05, 2012

Class II

Product summary

Firm
Apotex Corp.
Event
Event 62436
Status
Terminated
Classification
Class II
Quantity
1,749 Bottles
Official record key
drug-enforcement:D-1443-2012

Official wording

Reason: Tablet Thickness: Recall was initiated due to the presence of one slightly oversized tablet in a bottle of the identified lot.

Code information: Lot: 7212558, Exp 12/12.

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Tablet Thickness: Recall was initiated due to the presence of one slightly oversized tablet in a bottle of the identified lot.