Pramipexole Dihydrochloride Tablets 0.25 mg, 1000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. NDC 68382-197-10
Recall Number: D-1445-2019
Firm: Zydus Pharmaceuticals USA Inc
Classification: Class II
Status: Terminated
Report Date: 20190626
Initiation Date: 20190506
Termination Date: 20210916
Reason for Recall
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Product Description
Pramipexole Dihydrochloride Tablets 0.25 mg, 1000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. NDC 68382-197-10