Pantaprazole Sodium Delayed Release Tablets , USP 40 mg, 1000 tablets bottle, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd Parsippany, NJ 07054 USA. NDC: 64679-0434-02.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot: #: DM12286, Expiry: 06/14.
- 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:
- Failed Dissolution Specifications; 12 month acid dissolution test results were above upper limit specifications.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Pantaprazole Sodium Delayed Release Tablets , USP 40 mg, 1000 tablets bottle, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd Parsippany, NJ 07054 USA. NDC: 64679-0434-02.
Product Codes/Lot Numbers:
Lot: #: DM12286, Expiry: 06/14.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-1042-2014
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.