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Recall Observatory FDA recall evidence

Drug product

TESTOSTERONE CYPIONATE 50MG/ML INJ #1 IN ETHYL OLEATE INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

D-0184-2022

October 12, 2021

Class II

Product summary

Firm
Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Event
Event 88862
Status
Terminated
Classification
Class II
Quantity
40 vials
Official record key
drug-enforcement:D-0184-2022

Official wording

Reason: Lack of assurance of sterility

Code information: Lot: T0207282021:32 BUD: 11/20/2021; T0508162021:62 BUD: 02/12/2022; T0505242021:00 BUD: 11/20/2021; T0207232021:23 BUD: 11/20/2021

Distribution pattern: United States including Washington, D.C. and Puerto Rico

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility