Status
Ongoing
Drug Enforcement D-0280-2024
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 40 mg per 250 mL 0.9% Sodium Chloride (160 mcg per mL), Item F3352, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-150-82.
- Product quantity
- 12,564 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-0280-2024
- Event ID
- 93710
- Recall initiation date
- December 28, 2023
- Center classification date
- January 29, 2024
- Code info
- Lot #: 2330939, Exp. Date 01/30/2024; 2331032, Exp. Date 02/03/2024; 2331112, Exp. Date 03/19/2024; 2331190, Exp. Date 03/26/2024; 2331429, Exp. Date 04/28/2024.
- More code info
- —