Skip to content
Recall Observatory FDA recall evidence

Drug product

TRIPLE-TESTOSTERONE 250 MG/ML OIL INJ SOLN and TRIPLE-TESTOSTERONE 200 MG/ML OIL INJ SOLN, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-1007-2013

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-1007-2013

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: 07182013@1, 03202013@19, 01022013@31, 01292013@2, 04182013@10, 06142013@1, 07122013@1, 07132013@9

Distribution pattern: USA nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility