Drug product
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.
D-1042-2014
Product summary
- Event
- Event 67238
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1129 bottles
- Official record key
drug-enforcement:D-1042-2014
Official wording
Reason: Failed Dissolution Specifications; 12 month acid dissolution test results were above upper limit specifications.
Code information: Lot: #: DM12286, Expiry: 06/14.
Distribution pattern: Nationwide including Puerto Rico
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications