FDAFDA · Food and drugs·Recall number D-0721-2017
HYDROXO-B12 *1ML* SDV 1MG/ML INJ, Injection, 1mg/mL, Rx only, 1 mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy
Published May 24, 2017 · Recall initiated: April 18, 2017
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: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Key Pharmacy and Compounding Center
- Distributor
- Distributed nationwide in U.S.A., Australia and Canada.
- Lot
- Lot # t01-16-2017@91, Exp 4/17/2017; t02-08-2017@93, Exp 4/30/2017.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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