D-1124-2023 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- September 6, 2023
- Initiation Date
- August 17, 2023
- Termination Date
- March 27, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4100 syringes
Product Description
PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, 10 mL Syringe, Rx Only, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6009-1
Reason for Recall
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Distribution Pattern
Nationwide in the USA
Code Information
Lot# 36-262312, 36-262314, 36-262311, 36-262313, Exp 10/5/2023; 36-262739, 36-262742, 36-262741, 36-262740, 36-262738, 36-262737, Exp 10/11/2023. ;