FOLIC ACID 1ML SDV 10MG/ML INJ, Injection, 10mg/mL, Rx only, 1 mL glass/Single Dose vial, Prepare...
FDA Recall #D-0717-2017 — Class II — April 18, 2017
Product Description
FOLIC ACID 1ML SDV 10MG/ML INJ, Injection, 10mg/mL, Rx only, 1 mL glass/Single 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
20 vials
Distribution
Distributed nationwide in U.S.A., Australia and Canada.
Code Information
Lot # t01-20-2017@80, Exp 4/23/2017
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated