D-0303-2022 Class II Terminated

Recalled by SterRx, LLC — Plattsburgh, NY

FDA drug recall D-0303-2022 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: 9360 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
9360 bags

Product Description

NOREPINEPHRINE 4 mg per 250 mL (16 mcg per mL) in 5% Dextrose Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-451-01.

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

U.S.A. Nationwide

Code Information

S21192/BUV 18-Apr-22 S21205/BVH 23-Apr-22 S21402/CCK 21-Aug-22

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-0303-2022
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.

Source: openFDA record for D-0303-2022. Report a data issue: hello@regdatalab.com.