Recalls / Class II

Class IID-1274-2015

Product

Zonisamide Capsules, 25 mg Capsules, 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: 64679-0945-01.

Affected lot / code info

Lot #: LM10763, Expiry: 4/30/2015; Lot #: LM10764, Expiry: 4/30/2015; Lot #: LM10765, Expiry: 4/30/2015; Lot #: LM11142, Expiry: 6/30/2015; Lot #: LM11143, Expiry: 6/30/2015; Lot #: LM11144, Expiry: 6/30/2015; Lot #: LM11255, Expiry: 7/31/2015; Lot #: LM11256, Expiry: 7/31/2015; Lot #: LM11265, Expiry: 7/31/2015; Lot #: LM11542, Expiry: 8/31/2015; Lot #: LM11543, Expiry: 8/31/2015; Lot #: LN10197, Expiry: 12/31/2015; Lot #: LN10198, Expiry: 12/31/2015; Lot #: LN10199, Expiry: 12/31/2015; Lot #: LN10200, Expiry: 12/31/2015; Lot #: LN10202, Expiry: 12/31/2015; Lot #: LN10203, Expiry: 12/31/2015; Lot #: LN10395, Expiry: 1/31/2016; Lot #: LN10396, Expiry: 1/31/2016; Lot #: LN10531, Expiry: 2/29/2016; Lot #: LN10532, Expiry: 2/29/2016; Lot #: LN10533, Expiry: 2/29/2016; Lot #: LN10534, Expiry: 2/29/2016; Lot #: LN10796, Expiry: 2/29/2016; Lot #: LN10942, Expiry: 4/30/2016.

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

68,066 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-1274-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.