D-0444-2023 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 15, 2023
- Initiation Date
- February 21, 2023
- Termination Date
- January 11, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1212 units
Product Description
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
Reason for Recall
CGMP DEVIATIONS
Distribution Pattern
Nationwide within the United States including VA or other Government facilities
Code Information
Lot #: 2231017, Exp. Date 3/12/2023