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Recall Observatory FDA recall evidence

Drug product

Vitamin 10 B Lyophilized, Vial, For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC3321678338

D-0110-2020

September 12, 2019

Class II

Product summary

Firm
KRS Global Biotechnology, Inc
Event
Event 83789
Status
Terminated
Classification
Class II
Quantity
6747 vials
Official record key
drug-enforcement:D-0110-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: All lots remaining within expiry.

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility