Ephedrine Sulfate in 0.9% Sodium Chloride 5 mL, 25 mg/5 mL (5 mg/mL) Single-Dose Syringe, Rx Only...

FDA Recall #D-1062-2017 — Class II — July 14, 2017

Recall #D-1062-2017 Date: July 14, 2017 Classification: Class II Status: Terminated

Product Description

Ephedrine Sulfate in 0.9% Sodium Chloride 5 mL, 25 mg/5 mL (5 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222, NDC 52533-019-15

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

25529 syringes

Distribution

Nationwide within the US

Code Information

Lot #: 9910, 9928, BUD: 7/28/2017; 9962, 9993, BUD: 8/4/2017; 10333, 10481, 10538, BUD: 9/23/2017

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated