FDA-Drug2017-05-24Class II

HYDROXO-B12 5ML PBF MDV 1MG/ML INJ, Injection, 1mg/ml, Rx only, packaged in 5 mL Glass/ Multiple Dose and 30 mL Glass/ Multiple Dose vials,Prepared by Key Compounding Pharmacy

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
7 vials total (1/5mL vial and 6/30 mL vials)
Manufactured in
530 S 336th St, Federal Way, WA, United States
Products
HYDROXO-B12 5ML PBF MDV 1MG/ML INJ, Injection, 1mg/ml, Rx only, packaged in 5 mL Glass/ Multiple Dose and 30 mL Glass/ Multiple Dose vials,Prepared by Key Compounding Pharmacy

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0725-2017

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