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.

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

Code information: 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.

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