Home / Recalls / SterRx, LLC / D-0317-2022

D-0317-2022 Class II Terminated

Recalled by SterRx, LLC — Plattsburgh, NY

FDA drug recall D-0317-2022 was initiated by SterRx, LLC on Nov 12, 2021 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated Dec 6, 2023). Affected quantity: 5000 bags.

Recall Details

Product Type: Drugs
Report Date: Jan 5, 2022
Initiation Date: Nov 12, 2021
Termination Date: Dec 6, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 5000 bags

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

Distribution Pattern

U.S.A. Nationwide

Code Information

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

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0317-2022
openFDA file date: Nov 3, 2026
Loaded by RegDataLab: Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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