Ephedrine sulfate 5 mg/mL in 0.9% Sodium Chloride 10 mL in Single Dose Syringe, Total Volume 10 m...
FDA Recall #D-0156-2018 — Class II — December 7, 2017
Product Description
Ephedrine sulfate 5 mg/mL in 0.9% Sodium Chloride 10 mL in Single Dose Syringe, Total Volume 10 mL, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0600-12
Reason for Recall
Labeling: Incorrect or Missing Lot and/or Exp Date - product label was missing lot number and beyond use date.
Recalling Firm
SCA Pharmaceuticals — Little Rock, AR
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1248 syringes
Distribution
U.S.A. Nationwide
Code Information
Lot#: 20171013@30, Exp 12/27/2017
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated