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D-0965-2022 Class II Terminated

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

FDA drug recall D-0965-2022 was initiated by Nephron Sterile Compounding Center LLC on May 18, 2022 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated Aug 23, 2024). Affected quantity: 57810 syringes.

Recall Details

Product Type: Drugs
Report Date: Jun 8, 2022
Initiation Date: May 18, 2022
Termination Date: Aug 23, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 57810 syringes

Product Description

Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-955-10

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide in the USA

Code Information

Lots: PE1108A, Exp. 5/27/2022; PE2006A, Exp. 8/3/2022; PE2010A, Exp. 8/12/2022

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0965-2022
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 26, 2026

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

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