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Recall Observatory FDA recall evidence

Drug product

TESTOSTERONE BI-BLEND 100/100MG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

D-0168-2022

October 12, 2021

Class II

Product summary

Firm
Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Event
Event 88862
Status
Terminated
Classification
Class II
Quantity
1 vial
Official record key
drug-enforcement:D-0168-2022

Official wording

Reason: Lack of assurance of sterility

Code information: Lot: T7.803162021:08 BUD: 09/12/2021; TBB07142021:68 BUD: 01/10/2022

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