Drug product
Alcohol Prep Pads (Isopropyl Alcohol USP 70% v/v), 100 Individual Pads, Sterile, Distributed by Simple Diagnostics, Winston Park, NY NDC 98302-0001-05
D-0134-2018
Product summary
- Event
- Event 78657
- Status
- Terminated
- Classification
- Class II
- Quantity
- 150,250 alcohol pads
- Official record key
drug-enforcement:D-0134-2018
Official wording
Reason: Lack of Assurance of Sterility and cGMP Deviations
Code information: Lot # SD2070420925 Exp. Date 09/2019, and Lot # SD2070421201 and Lot # SD2070420601, Exp. Date 12/2019
Distribution pattern: Product was distributed throughout the United States
Derived failure modes
-
Manufacturing or process control
cGMP Deviations
-
Sterility assurance
Lack of Assurance of Sterility