FDAFDA · Food and drugs·Recall number D-0709-2017
5-MTHF 10ML SDV (CALIF) 5MG/ML INJ, Injection 5mg/mL, Rx only, 10mL 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 # t12-28-2016@113, Exp 6/27/2017.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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