PHENYLephrine HCL in 0.9% Sodium Chloride injectable, 10 mg (Final Concentration = 0.1 mg per mL)...
FDA Recall #D-0879-2017 — Class II — May 18, 2017
Product Description
PHENYLephrine HCL in 0.9% Sodium Chloride injectable, 10 mg (Final Concentration = 0.1 mg per mL) Total Volume 100 mL, Single Dose Container bag, Preservative Free (Contains Sulfites), Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC: 70004-0810-32
Reason for Recall
Lack of assurance of sterility: Product bags leaking at seam.
Recalling Firm
SCA Pharmaceuticals — Little Rock, AR
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
30 bags
Distribution
Nationwide in the USA
Code Information
LOT # 20170511@17, Use By: 08/09/17
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated