Zydus Pharmaceuticals USA Inc recalls Pramipexole Dihydrochloride Tablets 0.5 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad,
Recalled June 26, 2019 · FDA recall D-1446-2019 · Zydus Pharmaceuticals USA
Hazard
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. · FDA Class II
Units
168,330 90-count bottles
Sold at
Nationwide in the USA
Description
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
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
Manufacturer(s)
Zydus Pharmaceuticals USA Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →