Status
Terminated
Drug Enforcement D-0445-2023
CGMP DEVIATIONS
Classification
Class II
Report Date
March 15, 2023
Termination Date
January 11, 2024
Product Information
- 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
- Product quantity
- 8,136 units
- Reason for recall
- CGMP DEVIATIONS
- Recall initiation reason
- —
- Initial firm notification
- Distribution pattern
- Nationwide within the United States including VA or other Government facilities
Location & Firm
- Recalling firm
- Denver Solutions, LLC DBA Leiters Health
- Address
-
13796 Compark Blvd
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0445-2023
- Event ID
- 91762
- Recall initiation date
- February 21, 2023
- Center classification date
- March 7, 2023
- Code info
- 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
- More code info
- —