FDA-Drug2014-03-19Class I

Dextrose* Vial In Sterile Water, 50%, 50 mL Single Dose Vial, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Specialty Medicine Compounding Pharmacy, P.C.
Hazard

Non-Sterility: 50% dextrose is being recalled after particulate matter, later identified as mold, was found floating in the product.

Sold states
Hospitals, clinics, physicians, and patients in the Michigan area only.
Affected count
1000 vials
Manufactured in
350 S Lafayette St, N/A, South Lyon, MI, United States
Products
Dextrose* Vial In Sterile Water, 50%, 50 mL Single Dose Vial, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1156-2014

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