Home / Recalls / SterRx, LLC / D-0308-2022

D-0308-2022 Class II Terminated

Recalled by SterRx, LLC — Plattsburgh, NY

FDA drug recall D-0308-2022 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: 26,928 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: 26,928 bags

Product Description

EPINEPHIrine in 0.9% Sodium Chloride Injection, 4 mg per 250 mL (16 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-227-01.

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

U.S.A. Nationwide

Code Information

S21254/BWZ 22-Nov-21 S21263/BXG 30-Nov-21 S21333/BZT 11-Jan-22 S21398/CCG 19-Feb-22

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0308-2022
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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