Status
Terminated
Drug Enforcement D-0442-2023
CGMP DEVIATIONS
Classification
Class II
Report Date
March 15, 2023
Termination Date
January 11, 2024
Product Information
- Product description
- Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-11
- Product quantity
- 13,445 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-0442-2023
- Event ID
- 91762
- Recall initiation date
- February 21, 2023
- Center classification date
- March 7, 2023
- Code info
- Lot #: 2230960, Exp date 3/12/2023; 2231080, Exp date 4/9/2023.
- More code info
- —