Product: Pramipexole Dihydrochloride Tablets 0.125 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-196-10
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