Status
Terminated
Drug Enforcement D-296-2013
cGMP Deviations: Oral products were not manufactured in accordance with Good Manufacturing Practices.
Classification
Class II
Report Date
May 8, 2013
Termination Date
December 23, 2013
Product Information
- 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
- Product quantity
- 12770 bottles
- Reason for recall
- cGMP Deviations: Oral products were not manufactured in accordance with Good Manufacturing Practices.
- Recall initiation reason
- —
- Initial firm notification
- —
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Jubilant Cadista Pharmaceuticals Inc.
- Address
-
207 Kiley Dr
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-296-2013
- Event ID
- 64869
- Recall initiation date
- February 11, 2013
- Center classification date
- April 26, 2013
- Code info
- Lot PA22028 Exp 5/2014 Lot PA22029 Exp 5/2014
- More code info
- —