Class II · ModerateRecall completed
Pantoprazole Sodium Delayed Release Tablets
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot # PA218P008, PA218P009, Exp 04/2021
Where it was soldProduct was distributed to MS, OH, RI, TN and Puerto Rico to distributors and wholesalers who may have further distributed the product to the retail level.
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 Deviation: Presence of dark brown discoloration on edges of tablets.
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 Generics Ltd, Roorkee - 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals 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, packaged in 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd, Roorkee - 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-284-90 |
| Recalling firm | Jubilant Cadista Pharmaceuticals, Inc. |
| Distribution | Product was distributed to MS, OH, RI, TN and Puerto Rico to distributors and wholesalers who may have further distributed the product to the retail level. |
| Quantity | 63,216 bottles |
| Recall initiated | 2019-09-04 |
| Report date | 2019-10-23 |
| Recall completed | 2020-02-12 |
| Recall number | D-0145-2020 |
| 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.