Drug product
Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-11
D-0442-2023
Product summary
- Event
- Event 91762
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13,445 units
- Official record key
drug-enforcement:D-0442-2023
Official wording
Reason: CGMP DEVIATIONS
Code information: Lot #: 2230960, Exp date 3/12/2023; 2231080, Exp date 4/9/2023.
Distribution pattern: Nationwide within the United States including VA or other Government facilities
Derived failure modes
-
Manufacturing or process control
CGMP DEVIATIONS