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.
Reported: February 5, 2014 Initiated: November 27, 2013 #D-1042-2014
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.
Details
- Recalling Firm
- Wockhardt Usa Inc.
- Units Affected
- 1129 bottles
- Distribution
- Nationwide including Puerto Rico
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Wockhardt Usa Inc.. Units affected: 1129 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications; 12 month acid dissolution test results were above upper limit specifications.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 5, 2014. Severity: Moderate. Recall number: D-1042-2014.
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