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
FDA recall notice · announced May 8, 2013 · Jubilant Cadista Pharmaceuticals
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The 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
Reason for recall
cGMP Deviations: Oral products were not manufactured in accordance with Good Manufacturing Practices.
Notes
Distribution: Nationwide
Lot/code information: Lot PA22028 Exp 5/2014 Lot PA22029 Exp 5/2014
Quantity: 12770 bottles
Status: Terminated
Products in this recall event:
- 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, (D-296-2013)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.