Class II · ModerateRecall completed
Pantaprazole Sodium Delayed Release Tablets
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot: #: DM12286, Expiry: 06/14.
Where it was soldNationwide including Puerto Rico
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Failed Dissolution Specifications; 12 month acid dissolution test results were above upper limit specifications.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byWockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd Parsippany, NJ 07054 USA foreign manufacturer
| Distributed by / for | Wockhardt USA LLC 20 Waterview Blvd Parsippany, NJ 07054 USA |
| NDC | 64679-0434-02 |
Show the full FDA record
| Full product label | 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. |
| Recalling firm | Wockhardt Usa Inc. |
| Distribution | Nationwide including Puerto Rico |
| Quantity | 1129 bottles |
| Recall initiated | 2013-11-27 |
| Report date | 2014-02-05 |
| Recall completed | 2015-01-29 |
| Recall number | D-1042-2014 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Parsippany NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.