D-1273-2015 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 29, 2015
- Initiation Date
- April 22, 2015
- Termination Date
- May 9, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 84,542 Bottles
Product Description
Zonisamide Capsules, 50 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: 64679-0946-01.
Reason for Recall
CGMP Deviations: Firm did not adequately investigate customer complaints.
Distribution Pattern
U.S. Nationwide including Puerto Rico.
Code Information
Lot #: LM10769, Expiry: 4/30/2015; Lot #: LM10770, Expiry: 4/30/2015; Lot #: LM10771, Expiry: 4/30/2015; Lot #: LM10875, Expiry: 5/31/2015; Lot #: LM10876, Expiry: 5/31/2015; Lot #: LM11145, Expiry: 6/30/2015; Lot #: LM11174, Expiry: 6/30/2015; Lot #: LM11175, Expiry: 6/30/2015; Lot #: LM11226, Expiry: 7/31/2015; Lot #: LM11227, Expiry: 7/31/2015; Lot #: LM11289, Expiry: 7/31/2015; Lot #: LM11290, Expiry: 7/31/2015; Lot #: LM11544, Expiry: 8/31/2015; Lot #: LM11545, Expiry: 8/31/2015; Lot #: LM11671, Expiry: 9/30/2015; Lot #: LM11947, Expiry: 10/31/2015; Lot #: LM11948, Expiry: 10/31/2015; Lot #: LM11949, Expiry: 10/31/2015; Lot #: LM11950, Expiry: 10/31/2015; Lot #: LN10208, Expiry: 12/31/2015; Lot #: LN10209, Expiry: 12/31/2015; Lot #: LN10210, Expiry: 12/31/2015; Lot #: LN10211, Expiry: 12/31/2015; Lot #: LN10212, Expiry: 12/31/2015; Lot #: LN10213, Expiry: 12/31/2015; Lot #: LN10354, Expiry: 1/31/2016; Lot #: LN10355, Expiry: 1/31/2016; Lot #: LN10526, Expiry: 2/29/2016; Lot #: LN10527, Expiry: 2/29/2016; Lot #: LN10528, Expiry: 2/29/2016; Lot #: LN10529, Expiry: 2/29/2016; Lot #: LN10541, Expiry: 2/29/2016; Lot #: LN10840, Expiry: 4/30/2016; Lot #: LN11113, Expiry: 5/31/2016; Lot #: LN11333, Expiry: 7/31/2016; Lot #: LN11377, Expiry: 8/31/2016.