FDAFDA · Food and drugs·Recall number D-1042-2014
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.
Published February 5, 2014 · Recall initiated: November 27, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications; 12 month acid dissolution test results were above upper limit specifications.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Wockhardt Usa Inc.
- Distributor
- Nationwide including Puerto Rico
- Lot
- Lot: #: DM12286, Expiry: 06/14.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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