drugs Class II Updated 2014-02-05

Wockhardt Usa Inc. recalls Pantaprazole Sodium Delayed Release Tablets , USP 40 mg, 100

Recalled 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.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot: #: DM12286, Expiry: 06/14.
View official government recall

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