Key Pharmacy and Compounding Center recalls HYDROXO-B12 10ML PBF MDV 5MG/ML INJ, 5mg/mL, Rx only, 10 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharm
Recalled May 24, 2017 · FDA recall D-0724-2017 · Key Pharmacy and Compounding Center
Hazard
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. · FDA Class II
Units
8 vials total (6/10mL vials and 2/30 mL vials)
Sold at
Distributed nationwide in U.S.A., Australia and Canada.
Description
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Product
HYDROXO-B12 10ML PBF MDV 5MG/ML INJ, 5mg/mL, Rx only, 10 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy HYDROXO-B12 30ML PBF MDV 5MG/ML INJ, 5mg/mL, RX only, 30 mL Glass/ Multiple Dose vial.
Manufacturer(s)
Key Pharmacy and Compounding Center
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →