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Recall Observatory FDA recall evidence

Drug product

ESTRADIOL VALERATE 50MG/ML INJ #2 INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

D-0114-2022

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 vials
Official record key
drug-enforcement:D-0114-2022

Official wording

Reason: Lack of assurance of sterility

Code information: Lot: 09162021:22 BUD: 03/15/2022

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