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Recall Observatory FDA recall evidence

Drug product

GLUTATHIONE/METHYL/LIDO 100/25/20 MG/ML INJ SOLN and GLUTATHIONE/METHYL/LIDO 100/25/20MG/ML (PF) INJ SOLN, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-963-2013

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-963-2013

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: 06132013@6 04242013@33

Distribution pattern: USA nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility