ePHEDrine Sulfate In 0.9% Sodium Chloride, 5 mg per mL (50 mg per 10 mL), 10 mL Total Volume pre-...
FDA Recall #D-0220-2018 — Class II — October 30, 2017
Product Description
ePHEDrine Sulfate In 0.9% Sodium Chloride, 5 mg per mL (50 mg per 10 mL), 10 mL Total Volume pre-filled syringes, packaged in a) 5-count cartons, NDC 71030-0003-10 and NDC 71030-0003-20, and b) 25-count cartons, NDC 71030-0003-21 and NDC 71030-0003-12, Rx Only, PharMEDium Services, LLC, 913 N. Davis Ave, Cleveland, MS, Code 2R3304.
Reason for Recall
Subpotent Drug
Recalling Firm
Pharmedium Services, LLC — Lake Forest, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
5002 syringes
Distribution
Nationwide within the US
Code Information
Lot #: 172950036M, Exp. 1/21/2018; 172940003M, Exp. 1/20/2018; 172880044M, Exp. 1/14/2018; 172840176M, Exp. 1/11/2018; 172920115M, Exp. 1/18/2018; 172840015D, Exp. 1/10/2018; 172930139M, Exp. 1/19/2018.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated