Pramipexole DihydrochlorideTablets 0.125 mg, 90-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India. Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-196-16

Recall Number: D-1443-2019

Firm: Zydus Pharmaceuticals USA Inc

Classification: Class II

Status: Terminated

Report Date: 20190626

Initiation Date: 20190506

Termination Date: 20210916

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

Pramipexole DihydrochlorideTablets 0.125 mg, 90-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India. Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-196-16