Why it was recalled
cGMP Deviations: Oral products were not manufactured in accordance with Good Manufacturing Practices.
Product description
Pantoprazole Sodium Delayed Release Tablets USP, 40 mg, 90 count bottles, Manufactured by Jubilant Life Sciences Ltd, Roorkee-247661 India ;Marketed by Jubilant Cadista Pharmaceuatical Inc Salisbury, MD 21801 NDC 59746-284-90
Lot numbers, UPCs & expiration codes
Lot PA22028 Exp 5/2014 Lot PA22029 Exp 5/2014
Where it was sold
Nationwide
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-296-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 11, 2013
- FDA report date
- May 8, 2013
- Quantity
- 12770 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Jubilant Cadista Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-296-2013, exactly as published.
Show all FDA fields
- City
- Salisbury
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 64869
- Address
- 207 Kiley Dr
- Code information
- Lot PA22028 Exp 5/2014 Lot PA22029 Exp 5/2014
- Postal code
- 21801-2249
- Report date
- May 8, 2013
- Product type
- Drugs
- Recall number
- D-296-2013
- Classification
- Class II
- Recalling firm
- Jubilant Cadista Pharmaceuticals Inc.
- Product quantity
- 12770 bottles
- Termination date
- Dec 23, 2013
- Reason for recall
- cGMP Deviations: Oral products were not manufactured in accordance with Good Manufacturing Practices.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Pantoprazole Sodium Delayed Release Tablets USP, 40 mg, 90 count bottles, Manufactured by Jubilant Life Sciences Ltd, Roorkee-247661 India ;Marketed by Jubilant Cadista Pharmaceuatical Inc Salisbury, MD 21801 NDC 59746-284-90
- Distribution pattern
- Nationwide
- Recall initiation date
- Feb 11, 2013
- Center classification date
- Apr 26, 2013