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PHENYLephrine HCl, 40 mg per 250 mL, (160 mcg per mL) in 0.9% Sodium Chloride Injection, Rx Only,...

FDA Recall #D-0323-2022 — Class II — November 12, 2021

Recall #D-0323-2022 Date: November 12, 2021 Classification: Class II Status: Terminated

Product Description

PHENYLephrine HCl, 40 mg per 250 mL, (160 mcg per mL) in 0.9% Sodium Chloride Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-252-01.

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

20640 bags

Distribution

U.S.A. Nationwide

Code Information

S21087/BQX 16-Dec-21 S21151/BTJ 24-Jan-22 S21186/BUQ 14-Feb-22 S21189/BUS 16-Feb-22 S21266/BXJ 3-Apr-22 S21307/BYW 24-Apr-22 S21313/BZC 27-Apr-22

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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