Recalls / Class II
Class IID-0258-2023
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
- Affected lot / code info
- Lots: a) C030121, C021121, C021021, C030121, C030221, C021721; b) C012721, C012621, C012521, C021721; c) C042721
Why it was recalled
cGMP Deviations
Recalling firm
- Firm
- Frenda Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Calle A Lote 7 Parque Ind Las Cuevas, N/A, Trujillo Alto, Puerto Rico 00976
Distribution
- Quantity
- 44,140 bottles
- Distribution pattern
- Puerto Rico
Timeline
- Recall initiated
- 2022-12-15
- FDA classified
- 2023-01-30
- Posted by FDA
- 2023-02-08
- Terminated
- 2024-09-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0258-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.