FOLINIC ACID MDV INJ, Injection, 10 mg/mL, Rx only, packaged in 2mL and 10 mL glass/Multiple Dose...
FDA Recall #D-0719-2017 — Class II — April 18, 2017
Product Description
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
Reason for Recall
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Recalling Firm
Key Pharmacy and Compounding Center — Federal Way, WA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
12 vials total (3/2mL vials and 9/10mL vias)
Distribution
Distributed nationwide in U.S.A., Australia and Canada.
Code Information
Lot # t01-31-2017@128, Exp 5/2/2017; 01-31-2017@118, Exp 5/1/2017.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated