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FDAFDA · Food and drugs·Recall number D-979-2013

METHYLPREDNISOLONE ACETATE 40 MG/ML and 80 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

Published September 18, 2013 · Recall initiated: July 26, 2013

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Telephone

Recall details

Manufacturer
Beacon Hill Medical Pharmacy, P.C.
Distributor
USA nationwide
Lot
03192013@22, 03192013@24, 02132013@2
Risk classification
Class II
Area (FDA)
drug
Country
United States

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