Drug product
Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Pre-Filled Syringe, 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: 69374-957-10
D-0967-2022
Product summary
- Event
- Event 90211
- Status
- Terminated
- Classification
- Class II
- Quantity
- 585660 syringes
- Official record key
drug-enforcement:D-0967-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: PE1115B, PE1115C, Exp. 5/31/2022; PE1122A, Exp. 6/19/2022; PE2004B, PE2004C, Exp. 7/11/2022; PE2011A, PE2011C, Exp. 8/22/2022; PE2015A, PE2015B, PE2015C, Exp. 9/5/2022; PE2016A, PE2016B, PE2016C, Exp. 9/13/2022
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility