FDA-Drug2017-05-24Class II

FOLINIC ACID MDV INJ, Injection, 10 mg/mL, Rx only, packaged in 2mL and 10 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
12 vials total (3/2mL vials and 9/10mL vias)
Manufactured in
530 S 336th St, Federal Way, WA, United States
Products
FOLINIC ACID MDV INJ, Injection, 10 mg/mL, Rx only, packaged in 2mL and 10 mL glass/Multiple Dose vials, Prepared by Key Compounding Pharmacy

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0719-2017

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