Recalls / Class II
Class IID-1042-2014
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.
- Affected lot / code info
- Lot: #: DM12286, Expiry: 06/14.
Why it was recalled
Failed Dissolution Specifications; 12 month acid dissolution test results were above upper limit specifications.
Recalling firm
- Firm
- Wockhardt Usa Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 20 Waterview Blvd., Suite 3, Parsippany, New Jersey 07054
Distribution
- Quantity
- 1129 bottles
- Distribution pattern
- Nationwide including Puerto Rico
Timeline
- Recall initiated
- 2013-11-27
- FDA classified
- 2014-01-29
- Posted by FDA
- 2014-02-05
- Terminated
- 2015-01-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1042-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.