PHENYLephrine HCl, 50 mg per 250 mL, (200 mg per mL) in 0.9% Sodium Chloride Injection, Rx Only, ...
FDA Recall #D-0324-2022 — Class II — November 12, 2021
Product Description
PHENYLephrine HCl, 50 mg per 250 mL, (200 mg per mL) in 0.9% Sodium Chloride Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-901-01.
Reason for Recall
Lack of Assurance of Sterility
Recalling Firm
SterRx, LLC — Plattsburgh, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
23,136 bags
Distribution
U.S.A. Nationwide
Code Information
S21088/BQY 19-Dec-21 S21152/BTK 25-Jan-22 S21161/BTS 31-Jan-22 S21289/BYG 4-Apr-22 S21309/BYY 25-Apr-22 S21314/BZD 2-May-22 S21378/CBL 12-Jun-22
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated