FDA Drug Class II — Moderate

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.

Hazard

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

Products

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 Parsippan
Brand
Wockhardt Usa Inc.
UPC
Lot: #: DM12286, Expiry: 06/14.

Units Affected

1129 bottles