Why it was recalled
Discoloration: Presence of dark discoloration or brown spots 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 #: PA26038A, Exp 04/19; PA26039A, PA26040A, PA26050A, Exp 05/19; PA26052A, Exp 06/19; PA26073A, Exp 07/19; PA217071A, PA217072A, PA217073B, PA217074B, Exp 06/20; PA217101A, Exp 08/20; and PA218023A, Exp 01/21.
Where it was sold
Product was distributed Nationwide in the USA and Puerto Rico.
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-0011-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 2, 2018
- FDA report date
- Oct 17, 2018
- Quantity
- 158,466 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0011-2019, exactly as published.
Show all FDA fields
- City
- Salisbury
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 81162
- Address
- 207 Kiley Dr
- Code information
- Lot #: PA26038A, Exp 04/19; PA26039A, PA26040A, PA26050A, Exp 05/19; PA26052A, Exp 06/19; PA26073A, Exp 07/19; PA217071A, PA217072A, PA217073B, PA217074B, Exp 06/20; PA217101A, Exp 08/20; and PA218023A, Exp 01/21.
- Postal code
- 21801-2249
- Report date
- Oct 17, 2018
- Product type
- Drugs
- Recall number
- D-0011-2019
- Classification
- Class II
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Product quantity
- 158,466 bottles
- Termination date
- Feb 24, 2020
- Reason for recall
- Discoloration: Presence of dark discoloration or brown spots 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
- Product was distributed Nationwide in the USA and Puerto Rico.
- Recall initiation date
- Oct 2, 2018
- Initial firm notification
- Letter
- Center classification date
- Oct 9, 2018