Drug product
Easy Clean 70% Isopropyl Alcohol, packaged in a) 1 Gallon (128 fl. oz.) UPC 8 91857 00048 6; b) 16 fl. oz. (473 mL) UPC 8 91857 00047 9, Manufactured by: Frenda Corporation Trujillo Alto, PR 00976
D-0257-2023
Product summary
- Event
- Event 91325
- Status
- Terminated
- Classification
- Class II
- Quantity
- 65,376 bottles
- Official record key
drug-enforcement:D-0257-2023
Official wording
Reason: cGMP Deviations
Code information: Lots: a)C011721, C011421, C021721, C021521, C021421, C060321, C060221, C042821, C042721, C022521 , C011321; b) C011821, C011721, C052521, C051921, C052421, C030121, C022821
Distribution pattern: Puerto Rico
Derived failure modes
-
Manufacturing or process control
cGMP Deviations