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Recall Observatory FDA recall evidence

Drug product

QUAD-MIX PAPAV 30/PHENTOL 2/PGE-1 30/ATROPINE 0.2 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

D-0140-2022

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-0140-2022

Official wording

Reason: Lack of assurance of sterility

Code information: Lot: 08182021:31 BUD: 02/08/2022; 08262021:69 BUD: 02/08/2022; 08052021:40 BUD: 11/30/2021

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