Recalls / Class II

Class IID-1276-2015

Product

Captopril Tablets, USP, 50 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0904-01) and B) 1000 Count Bottles (NDC: 64679-0904-02), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

Affected lot / code info

A) Lot #: LM11093, Expiry: 6/30/2015; Lot #: LM11335, Expiry: 7/31/2015; Lot #: LM11336, Expiry: 7/31/2015; Lot #: LM11461, Expiry: 8/31/2015; Lot #: LM11462, Expiry: 8/31/2015; Lot #: LM11579, Expiry: 8/31/2015; Lot #: LM11778, Expiry: 9/30/2015; Lot #: LM11995, Expiry: 11/30/2015; Lot #: LN10029, Expiry: 11/30/2015; Lot #: LN10071, Expiry: 12/31/2015; Lot #: LN10349, Expiry: 1/31/2016; Lot #: LN10350, Expiry: 1/31/2016; Lot #: LN10505, Expiry: 2/29/2016; Lot #: LN10506, Expiry: 2/29/2016; Lot #: LN10814, Expiry: 3/31/2016; Lot #: LN10815, Expiry: 3/31/2016; Lot #: LN10977, Expiry: 4/30/2016; Lot #: LN11156, Expiry: 6/30/2016; Lot #: LN11260, Expiry: 7/31/2016. B) Lot #: LM10643, Expiry: 4/30/2015; Lot #: LM10846, Expiry: 5/31/2015; Lot #: LM11347, Expiry: 7/31/2015; Lot #: LM11492, Expiry: 8/31/2015; Lot #: LM11493, Expiry: 8/31/2015; Lot #: LM11577, Expiry: 8/31/2015; Lot #: LM11732, Expiry: 9/30/2015; Lot #: LM11994, Expiry: 11/30/2015; Lot #: LN10072, Expiry: 12/31/2015; Lot #: LN10073, Expiry: 12/31/2015; Lot #: LN10351, Expiry: 1/31/2016; Lot #: LN10561, Expiry: 2/29/2016; Lot #: LN10562, Expiry: 2/29/2016; Lot #: LN10816, Expiry: 3/31/2016; Lot #: LN10817, Expiry: 4/30/2016; Lot #: LN11162, Expiry: 6/30/2016; Lot #: LN11170, Expiry: 6/30/2016; Lot #: LN11171, Expiry: 6/30/2016.

Why it was recalled

CGMP Deviations: Firm did not adequately investigate customer complaints.

Recalling firm

Firm

Wockhardt Usa Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

20 Waterview Blvd Ste 3, N/A, Parsippany, New Jersey 07054-1271

Distribution

Quantity

A) 216,329 Bottles and B) 18,514 Bottles.

Distribution pattern

U.S. Nationwide including Puerto Rico.

Timeline

Recall initiated

2015-04-22

FDA classified

2015-07-17

Posted by FDA

2015-07-29

Terminated

2018-05-09

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1276-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.