Ephedrine Sulfate in 0.9% Sodium Chloride 10 mL, 50 mg/10 mL (5 mg/mL) Single-Dose Syringe, Rx On...
FDA Recall #D-1061-2017 — Class II — July 14, 2017
Product Description
Ephedrine Sulfate in 0.9% Sodium Chloride 10 mL, 50 mg/10 mL (5 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222, NDC 52533-019-12
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
24638 syringes
Distribution
Nationwide within the US
Code Information
Lot #: 9906, 9915 BUD: 7/28/2017; 9950, 9984, 10001,10010, BUD: 8/4/2017; 10064, BUD: 8/17/2017; 10341, 10452 BUD: 9/23/2017,
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated