D-0445-2023 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
- 8,136 units
Product Description
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
Reason for Recall
CGMP DEVIATIONS
Distribution Pattern
Nationwide within the United States including VA or other Government facilities
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