D-1252-2022 Class II Terminated
FDA drug recall D-1252-2022 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: 9410 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
- 9410 bags
Product Description
Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP, 2500 mcg/250 mL (10 mcg/mL*) bags, packaged as 10 x 1 IV bag per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-523-21
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide in the USA
Code Information
Lots: FN2001A, Exp. 7/8/2022; FN2001B, Exp. 7/8/2022; FN2002A, Exp. 7/19/2022; FN2002B, Exp. 7/19/2022; FN2003A, Exp. 8/24/2022; FN2003B, Exp. 8/24/2022
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1252-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026