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.
FDA recall notice · announced February 5, 2014 · Wockhardt
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The 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.
Reason for recall
Failed Dissolution Specifications; 12 month acid dissolution test results were above upper limit specifications.
Notes
Distribution: Nationwide including Puerto Rico
Lot/code information: Lot: #: DM12286, Expiry: 06/14.
Quantity: 1129 bottles
Status: Terminated
Products in this recall event:
- 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 (D-1042-2014)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.