Why it was recalled
CGMP Deviations: Presence of dark brown discoloration on edges of tablets
Product description
Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg, 90 count bottle, Rx Only, Manufactured by Jubilant Generics Ltd, Roorkee-247661 India, NDC 59746-284-90
Lot numbers, UPCs & expiration codes
Lot # PA218005A, exp. date 12/2020, PA218P010, PA218P011, exp. date 04/2021, PA218108A, PA218110A, exp. date 06/2021
Where it was sold
Distributed 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-1058-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 11, 2020
- FDA report date
- Mar 25, 2020
- Quantity
- 89,376 90-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1058-2020, exactly as published.
Show all FDA fields
- City
- Salisbury
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 85181
- Address
- 207 Kiley Dr
- Code information
- Lot # PA218005A, exp. date 12/2020, PA218P010, PA218P011, exp. date 04/2021, PA218108A, PA218110A, exp. date 06/2021
- Postal code
- 21801-2249
- Report date
- Mar 25, 2020
- Product type
- Drugs
- Recall number
- D-1058-2020
- Classification
- Class II
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Product quantity
- 89,376 90-count bottles
- Termination date
- Jun 10, 2020
- Reason for recall
- CGMP Deviations: Presence of dark brown discoloration on edges of 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, NDC 59746-284-90
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Mar 11, 2020
- Initial firm notification
- Letter
- Center classification date
- Mar 24, 2020