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Recall Observatory FDA recall evidence

Drug product

MIC/B12A 25/50/50MG/ML 1MG/ML MDV, Red Mountain Compounding Rx

D-0063-2022

August 13, 2021

Class II

Product summary

Firm
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Event
Event 88693
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-0063-2022

Official wording

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

Code information: all lots within expiry

Distribution pattern: 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility