Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, For Repackaging Only, Packaged in 4500 Count Pouches, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-140-00.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #: LN11086, Expiry: 5/31/2015.
- 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:
Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, For Repackaging Only, Packaged in 4500 Count Pouches, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-140-00.
Product Codes/Lot Numbers:
Lot #: LN11086, Expiry: 5/31/2015.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-1251-2015
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.