Recalls / Class II
Class IID-296-2013
Product
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
- Affected lot / code info
- Lot PA22028 Exp 5/2014 Lot PA22029 Exp 5/2014
Why it was recalled
cGMP Deviations: Oral products were not manufactured in accordance with Good Manufacturing Practices.
Recalling firm
- Firm
- Jubilant Cadista Pharmaceuticals Inc.
- Type
- Voluntary: Firm initiated
- Address
- 207 Kiley Dr, Salisbury, Maryland 21801-2249
Distribution
- Quantity
- 12770 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-02-11
- FDA classified
- 2013-04-26
- Posted by FDA
- 2013-05-08
- Terminated
- 2013-12-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-296-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.