Why it was recalled
Discoloration: Expansion of an earlier recall due to the presence of dark brown discoloration on the edges of the tablets.
Product description
Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 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.
Lot numbers, UPCs & expiration codes
Lot #: PA217060A, Exp 05/2020
Where it was sold
Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1074-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 29, 2019
- FDA report date
- Apr 10, 2019
- Quantity
- 12,960 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1074-2019, exactly as published.
Show all FDA fields
- City
- Salisbury
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 82523
- Address
- 207 Kiley Dr
- Code information
- Lot #: PA217060A, Exp 05/2020
- Postal code
- 21801-2249
- Report date
- Apr 10, 2019
- Product type
- Drugs
- Recall number
- D-1074-2019
- Classification
- Class II
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Product quantity
- 12,960 bottles
- Termination date
- Sep 20, 2019
- Reason for recall
- Discoloration: Expansion of an earlier recall due to the presence of dark brown discoloration on the edges of the tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 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.
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Mar 29, 2019
- Initial firm notification
- Letter
- Center classification date
- Apr 1, 2019