Sodium Bicarbonate 8.4% Injection Solution 50 mL, 50 mEq (1mEq/mL) Single-Dose Syringe, Rx Only,...
FDA Recall #D-1075-2017 — Class II — July 14, 2017
Product Description
Sodium Bicarbonate 8.4% Injection Solution 50 mL, 50 mEq (1mEq/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222
Reason for Recall
Lack of Sterility Assurance.
Recalling Firm
Cantrell Drug Company — Little Rock, AR
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
40081 syringes
Distribution
Nationwide within the US
Code Information
Lot#: 10349, BUD: 7/30/2017; 10356, BUD: 7/31/2017; 10377, BUD: 8/4/2017; 10386, BUD: 8/5/2017; 10394, BUD: 8/6/2017; 10404, BUD: 8/8/2017; 10423 BUD: 8/12/2017; 10468, BUD: 8/18/2017; 10473, BUD: 8/19/2017; 10482, BUD: 8/20/2017; 10514, BUD: 8/25/2017; 10524, BUD: 8/26/2017; 10569, BUD: 9/3/2017
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated