Drug product
Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL) syringe, packaged in 5 x 4 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: 69374-946-04
D-1262-2022
Product summary
- Event
- Event 90512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 184,370 syringes
- Official record key
drug-enforcement:D-1262-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: LB2002A, Exp. 7/12/2022; LB2004A, Exp. 8/21/2022; LB2006A, Exp. 9/3/2022; LB2008A, Exp. 10/6/2022
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility