FDA-Drug2013-05-08Class II

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

Jubilant Cadista Pharmaceuticals Inc.
Hazard

cGMP Deviations: Oral products were not manufactured in accordance with Good Manufacturing Practices.

Sold states
Nationwide
Affected count
12770 bottles
Manufactured in
207 Kiley Dr, Salisbury, MD, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-296-2013

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