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Recall Observatory FDA recall evidence

Drug product

Vancomycin HCl 1.5 g in 0.9% Sodium Chloride, 500 mL bags, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-0924-44

D-0831-2022

April 25, 2022

Class II

Product summary

Firm
SCA Pharmaceuticals
Event
Event 90080
Status
Terminated
Classification
Class II
Quantity
30 bags
Official record key
drug-enforcement:D-0831-2022

Official wording

Reason: CGMP Deviations

Code information: Lot #: 1222035839, Exp. Date 09-Aug-22

Distribution pattern: Product was distributed nationwide within the United States

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations