D-296-2013 Class II Terminated
FDA drug recall D-296-2013 was initiated by Jubilant Cadista Pharmaceuticals Inc. on Feb 11, 2013 and is designated Class II. Reason for recall: cGMP Deviations: Oral products were not manufactured in accordance with Good Manufacturing Practices. The recall status is terminated (terminated Dec 23, 2013). Affected quantity: 12770 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 8, 2013
- Initiation Date
- Feb 11, 2013
- Termination Date
- Dec 23, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12770 bottles
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
Reason for Recall
cGMP Deviations: Oral products were not manufactured in accordance with Good Manufacturing Practices.
Distribution Pattern
Nationwide
Code Information
Lot PA22028 Exp 5/2014 Lot PA22029 Exp 5/2014
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-296-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026