Drug product
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
D-1124-2023
Product summary
- Event
- Event 92898
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4100 syringes
- Official record key
drug-enforcement:D-1124-2023
Official wording
Reason: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
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. ;
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility