FDA recall D-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

Reason for recall

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-02-11

Report date

2013-05-08

Termination date

2013-12-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Salisbury, MD, United States

Primary source

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