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Recall Observatory FDA recall evidence

Drug product

S-TESTOSTERONE PROPIONATE 100MG/ML MDV IN SESAME OIL, Rx Only, 5ML glass vial, Red Mountain Compounding Rx.

D-0291-2020

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
2x10 ml glass vials
Official record key
drug-enforcement:D-0291-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #:S04222019DH@03 Exp 10/22/2019, S06162019DH@05, Exp 12/16/2019

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility