Skip to content
Recall Observatory FDA recall evidence

Drug product

TRI-MIX PAPAVERINE 30/PHENTOLAMINE 4/PGE-1 60 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

D-0222-2022

October 12, 2021

Class II

Product summary

Firm
Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Event
Event 88862
Status
Terminated
Classification
Class II
Quantity
3 vials
Official record key
drug-enforcement:D-0222-2022

Official wording

Reason: Lack of assurance of sterility

Code information: Lot: 07062021:22 BUD: 10/23/2021; 08262021:81 BUD: 02/22/2022

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