Drug product
Anticoagulant Sodium Citrate Solution, USP 4%, 200 mg/5 mL (40 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-906-05
D-1280-2022
Product summary
- Event
- Event 90512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 85,300 syringes
- Official record key
drug-enforcement:D-1280-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: SC2002A, Exp. 7/9/2022; SC2004A, Exp. 7/17/2022; SC2005A, Exp. 8/2/2022; SC2006A, Exp. 8/16/2022; SC2007A, Exp. 8/27/2022; SC2008A, Exp. 9/7/2022; SC2009A, Exp. 9/14/2022; SC2010A, Exp. 9/20/2022; SC2011A, Exp. 10/10/2022
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility