FDA recall D-1445-2019

Zydus Pharmaceuticals USA Inc · Class II · drug

Product

Pramipexole Dihydrochloride Tablets 0.25 mg, 1000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. NDC 68382-197-10

Reason for recall

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Distribution

Nationwide in the USA

Key facts

Status
Terminated
Initiation date
2019-05-06
Report date
2019-06-26
Termination date
2021-09-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Pennington, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1445-2019