Drug product
Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-148-94
D-0445-2023
Product summary
- Event
- Event 91762
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8,136 units
- Official record key
drug-enforcement:D-0445-2023
Official wording
Reason: CGMP DEVIATIONS
Code information: Lot #: 2231026, Exp. Date 2/23/2023; 2231051, Exp. Date 3/11/2023; 2231156, Exp. Date 5/29/2023; 2231163, Exp. Date 3/26/2023; 223130, Exp. Date 4 5/7/2023; 2231308, Exp. Date 5/11/2023
Distribution pattern: Nationwide within the United States including VA or other Government facilities
Derived failure modes
-
Manufacturing or process control
CGMP DEVIATIONS