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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Wockhardt Usa Inc.
- Reason for Recall:
- CGMP Deviations: Firm did not adequately investigate customer complaints.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
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.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-1273-2015
Related Recalls
Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for related compound.
CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.
CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.