Drug product
Easy Clean Antiseptic Hand Sanitizer Solution 65% with Glycerine, 1 Gallon (128 Fl. oz.), Manufactured by: Frenda Corporation Trujillo Alto, PR 00976, UPC 8 91857 00050 9
D-0254-2023
Product summary
- Event
- Event 91325
- Status
- Terminated
- Classification
- Class II
- Quantity
- 144 bottles
- Official record key
drug-enforcement:D-0254-2023
Official wording
Reason: cGMP Deviations
Code information: Lot: C013121
Distribution pattern: Puerto Rico
Derived failure modes
-
Manufacturing or process control
cGMP Deviations