FDA-Drug2017-05-24Class II
5-MTHF SDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, packaged in 1 mL, 2 mL, 5 mL, and 10 mL Glass/Single 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
63 vials total (29/1 mL vials; 30/2 mL vials; 3/5 mL vials, and 1/10 mL vial)
Manufactured in
530 S 336th St, Federal Way, WA, United States
Products
5-MTHF SDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, packaged in 1 mL, 2 mL, 5 mL, and 10 mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0710-2017Don't want to check this manually?
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