FDA recall D-0145-2020

Product

Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg, packaged in 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

CGMP Deviation: Presence of dark brown discoloration on edges of tablets.

Distribution

Product was distributed to MS, OH, RI, TN and Puerto Rico to distributors and wholesalers who may have further distributed the product to the retail level.

Key facts

Status

Terminated

Initiation date

2019-09-04

Report date

2019-10-23

Termination date

2020-02-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Salisbury, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0145-2020