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Recall Observatory FDA recall evidence

Drug product

Captopril Tablets, USP 12.5 mg, Rx Only, a) 100 count bottles NDC 64679-902-01, b) 1000 count bottles NDC 64679-902-02, Manufactured by Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt USA LLC., 20 Waterview Boulevard, Parsippany, NJ 07054 USA

D-0975-2015

March 12, 2015

Class II

Product summary

Firm
Wockhardt Usa Inc.
Event
Event 70740
Status
Terminated
Classification
Class II
Quantity
93,393 bottles
Official record key
drug-enforcement:D-0975-2015

Official wording

Reason: Failed Tablet/Capsule Specifications: out of specification for thickness.

Code information: Lot #s: a) LM10525, Exp 03/15; LM10727, Exp 04/15; LM11519, Exp 08/15; LN10008, Exp 11/15; LN10121, Exp 12/15; LN10887, Exp 04/16; LM11248, Exp 06/16 Lot #s: b) LM10522, Exp 03/15; LM10726, Exp 04/15; LN10007, Exp 11/15; LN10116, Exp 12/15; LN10888, Exp 04/16; LN11281 Exp 07/16

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification