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Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 2.5 mg per 250 mL, (10 mcg per mL), Rx Only,...

FDA Recall #D-0317-2022 — Class II — November 12, 2021

Recall #D-0317-2022 Date: November 12, 2021 Classification: Class II Status: Terminated

Product Description

Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 2.5 mg per 250 mL, (10 mcg per mL), Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-327-02.

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

5000 bags

Distribution

U.S.A. Nationwide

Code Information

S21353/CAM 26-Mar-22 S21358/CAR 30-Mar-22 S21364/CAX 6-Apr-22

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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