D-1442-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 26, 2019
- Initiation Date
- May 6, 2019
- Termination Date
- September 16, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 204 1000-count bottles
Product Description
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot: M714919, EXP Dec-19, M815081, EXP Aug-20, M900475, EXP Dec-20