Status
Ongoing
Drug Enforcement D-0279-2024
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Classification
Class I
Report Date
February 7, 2024
Termination Date
—
Product Information
- Product description
- PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-148-94.
- Product quantity
- 29,016 IV bags
- Reason for recall
- Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
- Recall initiation reason
- —
- Initial firm notification
- Distribution pattern
- Nationwide within the United States
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-0279-2024
- Event ID
- 93710
- Recall initiation date
- December 28, 2023
- Center classification date
- January 29, 2024
- Code info
- Lot #: 2330993, Exp. Date 02/15/2024; 2331010, Exp. Date 02/10/2024; 2331055, Exp. Date 01/18/2024; 2331113, Exp. Date 02/26/2024; 2331181, Exp. Date 03/04/2024; 2331187, Exp. Date 03/23/2024; 2331266, Exp. Date 03/31/2024; 2331343, Exp. Date 04/01/2024; 2331349, Exp. Date 04/23/2024; 2331433, Exp. Date 05/05/2024.
- More code info
- —