FDAClass IIJanuary 5, 2022

PHENYLephrine HCl recall: Sterility Concern

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…

Why was PHENYLephrine HCl recalled?

Lack of Assurance of Sterility

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
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…
Recalling firm
SterRx, LLC
Quantity
23,136 bags
Distribution
U.S.A. Nationwide
Recall date
January 5, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls