FDA recall D-0333-2021

Product

Itraconazole Capsules, 100 mg, 30-count bottles, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-282-30.

Reason for recall

Failed Dissolution Specifications

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2021-04-01

Report date

2021-04-21

Termination date

2022-04-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Salisbury, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0333-2021