Drug product
Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-150-82
D-0444-2023
Product summary
- Event
- Event 91762
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1212 units
- Official record key
drug-enforcement:D-0444-2023
Official wording
Reason: CGMP DEVIATIONS
Code information: Lot #: 2231017, Exp. Date 3/12/2023
Distribution pattern: Nationwide within the United States including VA or other Government facilities
Derived failure modes
-
Manufacturing or process control
CGMP DEVIATIONS