FDA recall D-1446-2019

Product

Pramipexole Dihydrochloride Tablets 0.5 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-198-16

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-1446-2019