PHENYLephrine HCl 100 mcg per mL In 0.9% Sodium Chloride 10 mL Fill Volume in a Single Dose Syrin...
FDA Recall #D-0066-2018 — Class II — October 19, 2017
Product Description
PHENYLephrine HCl 100 mcg per mL In 0.9% Sodium Chloride 10 mL Fill Volume in a Single Dose Syringe (1,000 mcg / 10 ml Total Dose), Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR, NDC 70004-0810-12
Reason for Recall
Lack Of Assurance Of Sterility.
Recalling Firm
SCA Pharmaceuticals, LLC — Little Rock, AR
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1221 syringes
Distribution
Nationwide in the United States
Code Information
Lot: 20170920@53 BUD: 12/19/2017
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated