US Drug Recall Register
Class II · Moderate risk Terminated Initiated Jul 26, 2013 (13 years ago)

SODIUM PHOSPHATE MONOBASIC/WATER FOR INJECTION 10%, all presentations, FOR INTRAVENO AND…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

What was recalled

SODIUM PHOSPHATE MONOBASIC/WATER FOR INJECTION 10%, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

Recalling firm
Beacon Hill Medical Pharmacy, P.C.
Origin
MI, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1001-2013

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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