Drug product
Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL) syringe, packaged in 5 x 10 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: 69374-955-10
D-1274-2022
Product summary
- Event
- Event 90512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 75,630 syringes
- Official record key
drug-enforcement:D-1274-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: PE2001A, Exp. 7/1/2022; PE2003A, Exp. 7/12/2022; PE2013A, Exp. 8/29/2022; PE2014A, Exp. 10/5/2022
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility