Drug product
PHENOL 2.5% STERILE SOLUTION in 50 mL syringe Assurance Infusion (713) 533-8800
D-0762-2020
Product summary
- Event
- Event 84546
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 syringes
- Official record key
drug-enforcement:D-0762-2020
Official wording
Reason: Lack of sterility assurance.
Code information: Lot: 10142019@14 Exp. 01/12/2020; 11042019@8 Exp. 02/02/2020
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Sterility assurance
Lack of sterility