SODIUM BICARB 50ML MDV 8.4% (2 MOSMOL/ML) INJ, Injection, 8.40%, Rx only, 5mL Glass/Multiple Do...
FDA Recall #D-0778-2017 — Class II — April 18, 2017
Product Description
SODIUM BICARB 50ML MDV 8.4% (2 MOSMOL/ML) INJ, Injection, 8.40%, Rx only, 5mL Glass/Multiple Dose via, 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
2 vials
Distribution
Distributed nationwide in U.S.A., Australia and Canada.
Code Information
Lot # t01-26-2017@94, Exp 4/27/2017
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated