FDA-Drug2013-09-18Class II

GLUTATHIONE/LIDO 100MG/2%/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

Beacon Hill Medical Pharmacy, P.C.
Hazard

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

Sold states
USA nationwide
Affected count
N/A
Manufactured in
18161 W 13 Mile Rd, Suite A1, Southfield, MI, United States
Products
GLUTATHIONE/LIDO 100MG/2%/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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-962-2013

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