FDA recall D-1074-2019

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: Expansion of an earlier recall due to the presence of dark brown discoloration on the edges of the tablets.

Distribution

Nationwide in the USA.

Key facts

Status

Terminated

Initiation date

2019-03-29

Report date

2019-04-10

Termination date

2019-09-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Salisbury, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1074-2019