Drug product
0.125% Bupivacaine HCl Injection, USP, 62.5 mg/50 mL (1.25 mg/mL) syringes, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Ext., West Columbia, SC 29172, NDC: 69374-970-50
D-1247-2022
Product summary
- Event
- Event 90512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6900 syringes
- Official record key
drug-enforcement:D-1247-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: BH2001A, Exp. 7/15/2022; BH2002A, Exp. 8/7/2022; BH2004A, Exp. 8/22/2022; BH2005A, Exp. 9/2/2022; BH2006A, Exp. 9/14/2022; BH2007A, Exp. 9/29/2022; BH2008A, Exp. 10/3/2022; BH2010A, Exp. 10/19/2022
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility