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Recall Observatory FDA recall evidence

Drug product

Clopidogrel Tablets USP, 75 mg, 90-count bottles, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8190-9

D-0513-2023

March 23, 2023

Class II

Product summary

Firm
Preferred Pharmaceuticals, Inc.
Event
Event 91952
Status
Ongoing
Classification
Class II
Quantity
72 Bottles
Official record key
drug-enforcement:D-0513-2023

Official wording

Reason: cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Code information: Lot: E0922W, G1222E, I0922W and K3022W Exp 10/31/2023.

Distribution pattern: USA Nationwide

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP Deviations