Skip to content
Recall Observatory FDA recall evidence

Drug product

FREAMINE III ALT. 8.5% INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-958-2013

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-958-2013

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: 03262013@11, 01212013@12, 02112013@17, 02262013@7, 03012013@17, 04102013@8, 04112013@7, 04292013@20, 05212013@4, 06042013@12, 06202013@3, 07152013@19, 07242013@14,

Distribution pattern: USA nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility