FDA Drug Recalls

Recalls / Class II

Class IID-0257-2023

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

Affected lot / code info
Lots: a)C011721, C011421, C021721, C021521, C021421, C060321, C060221, C042821, C042721, C022521 , C011321; b) C011821, C011721, C052521, C051921, C052421, C030121, C022821

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
65,376 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-0257-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls