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NOREPINEPHRINE 4 mg per 250 mL (16 mcg per mL) in 5% Dextrose Injection, Rx only, SterRx, 141 Ida...

FDA Recall #D-0303-2022 — Class II — November 12, 2021

Recall #D-0303-2022 Date: November 12, 2021 Classification: Class II Status: Terminated

Product Description

NOREPINEPHRINE 4 mg per 250 mL (16 mcg per mL) in 5% Dextrose Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-451-01.

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

9360 bags

Distribution

U.S.A. Nationwide

Code Information

S21192/BUV 18-Apr-22 S21205/BVH 23-Apr-22 S21402/CCK 21-Aug-22

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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