FDA recall D-0104-2021

Jubilant Cadista Pharmaceuticals, Inc. · Class II · drug

Product

clomiPRAMINE Hydrochloride Capsules USP, 50 mg, 30-count bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD NDC 59746-711-30

Reason for recall

Failed Tablet/Capsule Specification

Distribution

Product was distributed nationwide.

Key facts

Status
Terminated
Initiation date
2020-11-06
Report date
2020-12-02
Termination date
2022-03-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Salisbury, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0104-2021