Pantaprazole Sodium Delayed Release Tablets , USP 40 mg, 1000 tablets bottle, Rx only. Manufactur...
FDA Recall #D-1042-2014 — Class II — November 27, 2013
Product Description
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.
Recalling Firm
Wockhardt Usa Inc. — Parsippany, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1129 bottles
Distribution
Nationwide including Puerto Rico
Code Information
Lot: #: DM12286, Expiry: 06/14.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated