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D-1269-2022 Class II Terminated

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

FDA drug recall D-1269-2022 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: 1765 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: 1765 bags

Product Description

del Nido Cardioplegia Solution 1000 mL (1000 mL) Single-Dose Container IV bag, 4 x 1 IV Bag per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-984-10

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide in the USA

Code Information

Lots: NC2031A, Exp. 7/7/2022; NC2033A, Exp. 7/12/2022; NC2034A, Exp. 7/18/2022; NC2035A, Exp. 7/19/2022

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1269-2022
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.

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