Drug product
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
D-1252-2022
Product summary
- Event
- Event 90512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9410 bags
- Official record key
drug-enforcement:D-1252-2022
Official wording
Reason: Lack of Assurance of Sterility
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
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility