Why it was recalled
cGMP Deviations
Product description
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
Lot numbers, UPCs & expiration codes
Lot: C013121
Where it was sold
Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0254-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 15, 2022
- FDA report date
- Feb 8, 2023
- Quantity
- 144 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Frenda Corporation
Original FDA data
Every field from FDA enforcement report D-0254-2023, exactly as published.
Show all FDA fields
- City
- Trujillo Alto
- State
- PR
- Status
- Terminated
- Country
- United States
- Event ID
- 91325
- Address
- Calle A Lote 7 Parque Ind Las Cuevas
- Code information
- Lot: C013121
- Postal code
- 00976
- Report date
- Feb 8, 2023
- Product type
- Drugs
- Recall number
- D-0254-2023
- Classification
- Class II
- Recalling firm
- Frenda Corporation
- Product quantity
- 144 bottles
- Termination date
- Sep 10, 2024
- Reason for recall
- cGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Puerto Rico
- Recall initiation date
- Dec 15, 2022
- Initial firm notification
- Letter
- Center classification date
- Jan 30, 2023