D-0311-2022 Class II Terminated

Recalled by SterRx, LLC — Plattsburgh, NY

FDA drug recall D-0311-2022 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: 684 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
684 bags

Product Description

EPINEPHrine in 0.9% Sodium Chloride Injection, 16 mg per 250 mL (64 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-627-01.

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

U.S.A. Nationwide

Code Information

S21335/BZV

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-0311-2022
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-0311-2022. Report a data issue: hello@regdatalab.com.