Skip to content
Recall Observatory FDA recall evidence

Drug product

TRI-MIX 10 MCG/30 MG/1 MG/ML INJ SOLN and TRI-MIX 30 MCG/15 MG/2 MG/ML INJ SOLN, all configuration, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-1005-2013

July 26, 2013

Class II

Product summary

Firm
Beacon Hill Medical Pharmacy, P.C.
Event
Event 65876
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-1005-2013

Official wording

Reason: Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information: 04302013@22, 02132013@8, 04122013@27, 06262013@28

Distribution pattern: USA nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility