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Recall Observatory FDA recall evidence

Drug 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

D-1443-2019

May 06, 2019

Class II

Product summary

Firm
Zydus Pharmaceuticals USA Inc
Event
Event 82827
Status
Terminated
Classification
Class II
Quantity
143,184 90-count bottles
Official record key
drug-enforcement:D-1443-2019

Official wording

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

Code information: Lot: M714176, M714177, EXP Oct-19; M714917, EXP Nov-19; M714918, M715594, M715595, EXP Dec-19; M802190, EXP Jan-20; M802191, EXP Feb-20, M808673, EXP May-20; M811125, M811126, M811127, M811128, M811129, EXP Jun-20; M815082, M815083, M815084, M815085, M815086 EXP Aug-20; M900476, M900477, M900478, M900479, M900481, Dec-20;

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations