D-0442-2023 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
- 13,445 units
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
Reason for Recall
CGMP DEVIATIONS
Distribution Pattern
Nationwide within the United States including VA or other Government facilities
Code Information
Lot #: 2230960, Exp date 3/12/2023; 2231080, Exp date 4/9/2023.