FDA-Drug2017-05-24Class II
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.
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
8 vials total (6/10mL vials and 2/30 mL vials)
Manufactured in
530 S 336th St, Federal Way, WA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0724-2017Don't want to check this manually?
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