Home / Recalls / SterRx, LLC / D-0931-2023

D-0931-2023 Class II Terminated

Recalled by SterRx, LLC — Plattsburgh, NY

FDA drug recall D-0931-2023 was initiated by SterRx, LLC on Jul 7, 2023 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated Jul 8, 2024). Affected quantity: 132,299 bags.

Recall Details

Product Type: Drugs
Report Date: Jul 26, 2023
Initiation Date: Jul 7, 2023
Termination Date: Jul 8, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 132,299 bags

Product Description

Norepinephrine 4 mg per 250 mL (16 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-552-01.

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide in the USA

Code Information

Lot #: 490062, Exp 22-Jul-23; 490151, Exp 28-Jul-23; 490732, Exp 6-Aug-23; 491591, Exp 17-Aug-23; 491604, Exp 18-Aug-23; 494418, Exp 16-Nov-23; 494426, Exp 17-Nov-23; 494434, Exp 23-Nov-23; 496755, Exp 25-Nov-23; 497424, Exp 3-Dec-23; 497432, Exp 4-Dec-23; 497441, 497459, Exp 7-Dec-23; 498005, Exp 10-Dec-23; 499075, Exp 22-Jan-24; 499083, 499091, Exp 25-Jan-24; 499391, Exp 26-Jan-24; 501964, Exp 23-Mar-24; 501972, Exp 28-Mar-24; 501981, Exp 30-Mar-24; 501999, Exp 6-Apr-24; 502001, Exp 7-Apr-24

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0931-2023
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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D-0314-2022 Class II — NOREPINEPHRINE in 5% Dextrose Injection, 8 mg per 250 mL (32 mg per mL)… (Nov 12, 2021)