FDA recall D-0011-2019

Product

Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801; NDC 59746-284-90.

Reason for recall

Discoloration: Presence of dark discoloration or brown spots on the edges of the tablets.

Distribution

Product was distributed Nationwide in the USA and Puerto Rico.

Key facts

Status

Terminated

Initiation date

2018-10-02

Report date

2018-10-17

Termination date

2020-02-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Salisbury, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0011-2019