Recalls / Class II
Class IID-0254-2023
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
- Affected lot / code info
- Lot: C013121
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
- 144 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-0254-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.