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Recall Observatory FDA recall evidence

Drug product

Captopril Tablets, USP, 100 mg Tablets, Packaged in 100 Count Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0905-01.

D-1277-2015

April 22, 2015

Class II

Product summary

Firm
Wockhardt Usa Inc.
Event
Event 71104
Status
Terminated
Classification
Class II
Quantity
68,969 Bottles
Official record key
drug-enforcement:D-1277-2015

Official wording

Reason: CGMP Deviations: Firm did not adequately investigate customer complaints.

Code information: Lot #: LM11354, Expiry: 7/31/2015; Lot #: LM11355, Expiry: 7/31/2015; Lot #: LM11374, Expiry: 7/31/2015; Lot #: LM11626, Expiry: 8/31/2015; Lot #: LM12004, Expiry: 11/30/2015; Lot #: LM12005, Expiry: 11/30/2015; Lot #: LN10080, Expiry: 10/31/2015; Lot #: LN10393, Expiry: 1/31/2016; Lot #: LN10447, Expiry: 1/31/2016; Lot #: LN10736, Expiry: 2/29/2016; Lot #: LN11316, Expiry: 7/31/2016.

Distribution pattern: U.S. Nationwide including Puerto Rico.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations