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Recall Observatory FDA recall evidence

Drug product

S-TRIMIX (40MG/2.5MG/29MCG) MDV INJ; Rx Only, 5ml glass vial, Red Mountain Compounding Rx

D-0295-2020

August 12, 2019

Class II

Product summary

Firm
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Event
Event 83669
Status
Terminated
Classification
Class II
Quantity
1x5 ml glass vial
Official record key
drug-enforcement:D-0295-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #:S06092019DH@04, Exp 8/9/19;

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility