Key Pharmacy and Compounding Center recalls HYDROXO-B12 1ML SDV 10MG/ML INJ, Injection, 10mg/mL, Rx only, 1 mL glass/ Single Dose vial, Prepared by Key Compounding
Recalled May 24, 2017 · FDA recall D-0722-2017 · 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
50 vials total (10/1mL vials and 40/2mL 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 1ML SDV 10MG/ML INJ, Injection, 10mg/mL, Rx only, 1 mL glass/ Single Dose vial, Prepared by Key Compounding Pharmacy HYDROXO-B12 2ML SDV 10MG/ML INJ, Injection, 10mg/mL, RX only, 2 mL glass/ Single Dose vial.
Manufacturer(s)
Key Pharmacy and Compounding Center
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →