fentaNYL Citrate in 0.9% Sodium Chloride, 2.5 mg per 250 mL, (10 mcg per mL) IV bags, Rx Only, St...

FDA Recall #D-1332-2022 — Class II — July 25, 2022

Recall #D-1332-2022 Date: July 25, 2022 Classification: Class II Status: Terminated

Product Description

fentaNYL Citrate in 0.9% Sodium Chloride, 2.5 mg per 250 mL, (10 mcg per mL) IV bags, Rx Only, SterRx, 141 Idaho Avenue, 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

360 bags

Distribution

Nationwide within the United States

Code Information

Lot #: CHL, Exp. Date Dec 29, 2022

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated