Zydus Pharmaceuticals USA Inc recalls Pramipexole DihydrochlorideTablets 0.125 mg, 90-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd Ahmedabad,
Recalled June 26, 2019 · FDA recall D-1443-2019 · Zydus Pharmaceuticals USA
Hazard
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. · FDA Class II
Units
143,184 90-count bottles
Sold at
Nationwide in the USA
Description
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Product
Pramipexole DihydrochlorideTablets 0.125 mg, 90-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India. Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-196-16
Manufacturer(s)
Zydus Pharmaceuticals USA Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →