Drug product
Bupivacaine HCl 150 mg (3.0 mg/mL), Ketorolac Tromethamine 60 mg (1.2 mg/mL), Ketamine HCl 60 mg (1.2 mg/mL) Injection, 50 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. Extension, West Columbia, SC 29172, NDC: 69374-514-50
D-1249-2022
Product summary
- Event
- Event 90512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2315 syringes
- Official record key
drug-enforcement:D-1249-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: BP2001A, Exp. 7/6/2022; BP2002A, Exp. 7/27/2022; BP2007A, Exp. 7/3/2022
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility