Drug product
Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 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: 69374-955-10
D-0965-2022
Product summary
- Event
- Event 90211
- Status
- Terminated
- Classification
- Class II
- Quantity
- 57810 syringes
- Official record key
drug-enforcement:D-0965-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: PE1108A, Exp. 5/27/2022; PE2006A, Exp. 8/3/2022; PE2010A, Exp. 8/12/2022
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility