Wockhardt Usa Inc. recalls Pantaprazole Sodium Delayed Release Tablets , USP 40 mg, 1000 tablets bottle, Rx only. Manufactured by: Wockhardt Limite
Recalled February 5, 2014 · FDA recall D-1042-2014 · Wockhardt Usa
Hazard
Failed Dissolution Specifications; 12 month acid dissolution test results were above upper limit specifications. · FDA Class II
Units
1129 bottles
Sold at
Nationwide including Puerto Rico
Description
Failed Dissolution Specifications; 12 month acid dissolution test results were above upper limit specifications.
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.
Manufacturer(s)
Wockhardt Usa Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →