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.

Recall Number: D-1042-2014

Firm: Wockhardt Usa Inc.

Classification: Class II

Status: Terminated

Report Date: 20140205

Initiation Date: 20131127

Termination Date: 20150129

Failed Dissolution Specifications; 12 month acid dissolution test results were above upper limit specifications.

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.