Why it was recalled
Failed Dissolution Specifications; 12 month acid dissolution test results were above upper limit specifications.
Product 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.
Lot numbers, UPCs & expiration codes
Lot: #: DM12286, Expiry: 06/14.
Where it was sold
Nationwide including Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1042-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 27, 2013
- FDA report date
- Feb 5, 2014
- Quantity
- 1129 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Wockhardt Usa Inc.
Original FDA data
Every field from FDA enforcement report D-1042-2014, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 67238
- Address
- 20 Waterview Blvd., Suite 3
- Code information
- Lot: #: DM12286, Expiry: 06/14.
- Postal code
- 07054
- Report date
- Feb 5, 2014
- Product type
- Drugs
- Recall number
- D-1042-2014
- Classification
- Class II
- Recalling firm
- Wockhardt Usa Inc.
- Product quantity
- 1129 bottles
- Termination date
- Jan 29, 2015
- Reason for recall
- Failed Dissolution Specifications; 12 month acid dissolution test results were above upper limit specifications.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product 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.
- Distribution pattern
- Nationwide including Puerto Rico
- Recall initiation date
- Nov 27, 2013
- Initial firm notification
- Letter
- Center classification date
- Jan 29, 2014