PHENYLepherine HCL in 0.9% Sodium Chloride, 20 mg per 250 mL (80 mcg per mL), Rx only, SterRx, 14...
FDA Recall #D-0305-2022 — Class II — November 12, 2021
Product Description
PHENYLepherine HCL in 0.9% Sodium Chloride, 20 mg per 250 mL (80 mcg per mL), Rx only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-701-01.
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
18,948 bags
Distribution
U.S.A. Nationwide
Code Information
S21086/BQW 14-Dec-21 S21149/BTH 23-Jan-22 S21159/BTQ 30-Jan-22 S21265/BXI 3-Apr-22 S21305/BYU 24-Apr-22 S21311/BZA 26-Apr-22
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated