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FDAFDA · Food and drugs·Recall number D-946-2013

CYANOCOBALAMIN 1000 MCG/ML 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

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
01092013@12, 02132013@17, 03122013@21, 04122013@33, 05132013@17 05282013@26, 06052013@33, 06252013@4, 06272013@2, 07152013@41
Risk classification
Class II
Area (FDA)
drug
Country
United States

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