FOLINIC ACID MDV (CALIF) 5MG/ML INJ, Injection, 5mg/mL, Rx only, packaged in 5 mL and10 mL glass/...
FDA Recall #D-0718-2017 — Class II — April 18, 2017
Product Description
FOLINIC ACID MDV (CALIF) 5MG/ML INJ, Injection, 5mg/mL, Rx only, packaged in 5 mL and10 mL glass/ Multiple Dose vial, 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
3 vials total
Distribution
Distributed nationwide in U.S.A., Australia and Canada.
Code Information
Lot # t02-09-2017@74, Exp 5/15/2017; t02-17-2017@89, Exp 5/21/2017; t02-20-2017@72, Exp 5/22/2017.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated