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Recall Observatory FDA recall evidence

Drug product

TEST CYP (Grapeseed) 200 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

D-1522-2022

August 26, 2022

Class II

Product summary

Firm
Carolina Infusion
Event
Event 90798
Status
Completed
Classification
Class II
Quantity
2 vials
Official record key
drug-enforcement:D-1522-2022

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lots: 06132022@5 BUD: 09/11/2022; 08082022@17 BUD: 11/06/2022

Distribution pattern: Nationwide in the USA.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility