Drug product
Phenylephrine HCl in 0.9% Sodium Chloride Injection, USP, 50 mg/250 mL (200 mcg/mL), 250 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-321-25.
D-0362-2023
Product summary
- Event
- Event 91749
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10,980 bottles
- Official record key
drug-enforcement:D-0362-2023
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: PS2008A, Exp. 03/07/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility