Drug product
Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-301-10.
D-0361-2023
Product summary
- Event
- Event 91749
- Status
- Terminated
- Classification
- Class II
- Quantity
- 24,870 vials
- Official record key
drug-enforcement:D-0361-2023
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: PE2029, Exp. 06/17/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility