Why it was recalled
CGMP Deviation: Presence of dark brown discoloration on edges of tablets.
Product description
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
Lot numbers, UPCs & expiration codes
Lot # PA218P008, PA218P009, Exp 04/2021
Where it was sold
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.
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-0145-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 4, 2019
- FDA report date
- Oct 23, 2019
- Quantity
- 63,216 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0145-2020, exactly as published.
Show all FDA fields
- City
- Salisbury
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 83705
- Address
- 207 Kiley Dr
- Code information
- Lot # PA218P008, PA218P009, Exp 04/2021
- Postal code
- 21801-2249
- Report date
- Oct 23, 2019
- Product type
- Drugs
- Recall number
- D-0145-2020
- Classification
- Class II
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Product quantity
- 63,216 bottles
- Termination date
- Feb 12, 2020
- Reason for recall
- CGMP Deviation: Presence of dark brown discoloration on edges of tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- 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.
- Recall initiation date
- Sep 4, 2019
- Initial firm notification
- Letter
- Center classification date
- Oct 17, 2019