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.
Recall initiated: 20190506
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated