Drug product
Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Pre-Filled Syringes, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-956-10
D-0966-2022
Product summary
- Event
- Event 90211
- Status
- Terminated
- Classification
- Class II
- Quantity
- 76860 syringes
- Official record key
drug-enforcement:D-0966-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: PE1107A, Exp. 5/22/2022; PE1123A, Exp. 6/21/2022; PE2007A, Exp. 8/4/2022; PE2012A, Exp. 8/28/2022
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility