Ephedrine Sulfate Injection Solution 1 mL, 50 mg/1 mL (50 mg/mL) Single-Dose Syringe, Rx Only, ...
FDA Recall #D-1063-2017 — Class II — July 14, 2017
Product Description
Ephedrine Sulfate Injection Solution 1 mL, 50 mg/1 mL (50 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222, NDC 52533-258-45
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
7656 syringes
Distribution
Nationwide within the US
Code Information
Lot #: 10099, BUD: 7/27/2017; 10127, BUD: 8/1/2017; 10208, BUD: 8/10/2017; 10254, BUD: 8/15/2017; 10278, BUD: 8/17/2017; 10303, BUD: 8/21/2017; 10371, BUD: 9/3/2017; 10457, BUD: 9/17/2017
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated