D-1273-2022 Class II Terminated

Recalled by Nephron Sterile Compounding Center LLC — West Columbia, SC

FDA drug recall D-1273-2022 was initiated by Nephron Sterile Compounding Center LLC on Jun 30, 2022 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated Jun 17, 2024). Affected quantity: 1810 bags.

Recall Details

Product Type
Drugs
Report Date
Jul 27, 2022
Initiation Date
Jun 30, 2022
Termination Date
Jun 17, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1810 bags

Product Description

Oxytocin 30 Units/500 mL (0.06 Units/mL) in 0.9% Sodium Chloride Injection, USP IV bag, packaged in 10 x 1 IV Bag per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-543-50

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide in the USA

Code Information

Lots: OX2013C, Exp. 7/9/2022; OX2013E, Exp. 7/9/2022

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-1273-2022
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 25, 2026

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