Reported Feb 5, 2014 · Terminated
Pantaprazole Sodium Delayed Release Tablets , USP 40 mg, 1000 tablets bottle, Rx only. Manufactured by: Wockhardt…
Wockhardt USA Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Wockhardt Usa Inc. · 20 Waterview Blvd., Suite 3 · Parsippany, NJ · 07054
Is this the product you have?
- Pantaprazole Sodium Delayed Release Tablets , USP 40 mg, 1000 tablets bottle, Rx only
- Manufactured byWockhardt Limited, Mumbai, India
- Distributed byWockhardt USA LLC 20 Waterview Blvd Parsippany, NJ 07054 USA
- NDC64679-0434-02
- Lot codes and dates
- Lot#: DM12286
- Expiry06/14
- Amount recalled
- 1129 bottles
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed Dissolution Specifications; 12 month acid dissolution test results were above upper limit specifications.
This product could cause temporary or reversible health problems — stop using it.
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