Skip to content
Recall Observatory FDA recall evidence

Drug product

Pramipexole Dihydrochloride Tablets 1 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-199-16

D-1447-2019

May 06, 2019

Class II

Product summary

Firm
Zydus Pharmaceuticals USA Inc
Event
Event 82827
Status
Terminated
Classification
Class II
Quantity
113,304 90-count bottles
Official record key
drug-enforcement:D-1447-2019

Official wording

Reason: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Code information: Lots: M714186 M714187 M714188 EXP Oct-19; M714903 M714904 M714905 M715586 M715587 EXP Nov-19; M801441 M801442 M801443 M801444 M801445 EXP Dec-19; M811152 M811153 M811154 M811155 M811156 M814298 EXP Jul-20; M814299 M814300 M814301 M814302 EXP Aug-20; M818136 M818137 M818138 M818139 M818140 EXP Nov-20

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations