Key Pharmacy and Compounding Center recalls 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, Prep
Recalled May 24, 2017 · FDA recall D-0710-2017 · 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. · FDA Class II
Units
63 vials total (29/1 mL vials; 30/2 mL vials; 3/5 mL vials, and 1/10 mL vial)
Sold at
Distributed nationwide in U.S.A., Australia and Canada.
Description
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Product
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
Manufacturer(s)
Key Pharmacy and Compounding Center
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →