ePHEDrine Sulfate 5 mg/mL in NS 5 mL Fill in 12 mL Syringe (25 mg), Rx only, SCA Pharmaceuticals ...
FDA Recall #D-1018-2017 — Class II — July 14, 2017
Product Description
ePHEDrine Sulfate 5 mg/mL in NS 5 mL Fill in 12 mL Syringe (25 mg), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0600-11
Reason for Recall
Lack of Assurance of Sterility; product has the potential to leak.
Recalling Firm
SCA Pharmaceuticals — Little Rock, AR
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
N/A
Distribution
Nationwide
Code Information
Lots: 20170503@28 BUD: 7/17/2017; 20170508@60 BUD: 7/22/2017
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated