Class II · ModerateRecall completed
Pantoprazole Sodium Delayed Release Tablets USP
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot PA22028 Exp 5/2014 Lot PA22029 Exp 5/2014
Where it was soldNationwide
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
cGMP Deviations: Oral products were not manufactured in accordance with Good Manufacturing Practices.
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 byJubilant Life Sciences Ltd, Roorkee-247661 India ;Marketed by Jubilant Cadista Pharmaceuatical Inc Salisbury, MD 21801 foreign manufacturer
| Distributed by / for | Jubilant Cadista Pharmaceuticals Inc. |
| NDC | 59746-284-90 |
Show the full FDA record
| Full product label | Pantoprazole Sodium Delayed Release Tablets USP, 40 mg, 90 count bottles, Manufactured by Jubilant Life Sciences Ltd, Roorkee-247661 India ;Marketed by Jubilant Cadista Pharmaceuatical Inc Salisbury, MD 21801 NDC 59746-284-90 |
| Recalling firm | Jubilant Cadista Pharmaceuticals Inc. |
| Distribution | Nationwide |
| Quantity | 12770 bottles |
| Recall initiated | 2013-02-11 |
| Report date | 2013-05-08 |
| Recall completed | 2013-12-23 |
| Recall number | D-296-2013 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Salisbury MD 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.