Drug product
Easy Clean 75% Ethyl Alcohol, packaged in a) 1 Gallon (128 fl. oz.) UPC 8 91857 00045 5; b) 16 fl. oz. (473 mL) UPC 8 91857 00055 4; c) Rubbing Alcohol 10 fl. oz. (296 mL) UPC 8 91857 00044 8, Manufactured by Frenda Corporation Trujillo Alto, PR 00976
D-0258-2023
Product summary
- Event
- Event 91325
- Status
- Terminated
- Classification
- Class II
- Quantity
- 44,140 bottles
- Official record key
drug-enforcement:D-0258-2023
Official wording
Reason: cGMP Deviations
Code information: Lots: a) C030121, C021121, C021021, C030121, C030221, C021721; b) C012721, C012621, C012521, C021721; c) C042721
Distribution pattern: Puerto Rico
Derived failure modes
-
Manufacturing or process control
cGMP Deviations