FDA-Drug2017-05-24Class II
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.
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.
Sold states
Distributed nationwide in U.S.A., Australia and Canada.
Affected count
50 vials total (10/1mL vials and 40/2mL vials)
Manufactured in
530 S 336th St, Federal Way, WA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0722-2017Don't want to check this manually?
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