FDAFDA · Food and drugs·Recall number D-953-2013
EDETATE DISODIUM 150 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
- 07172013@4, 01222013@14, 03072013@10, 04032013@1, 05162013@17, 06042013@30m, 07092013@17, and 07262013@2
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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