Why it was recalled
cGMP Deviations
Product description
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
Lot numbers, UPCs & expiration codes
Lots: a) C030121, C021121, C021021, C030121, C030221, C021721; b) C012721, C012621, C012521, C021721; c) C042721
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-0258-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 15, 2022
- FDA report date
- Feb 8, 2023
- Quantity
- 44,140 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Frenda Corporation
Original FDA data
Every field from FDA enforcement report D-0258-2023, 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
- Lots: a) C030121, C021121, C021021, C030121, C030221, C021721; b) C012721, C012621, C012521, C021721; c) C042721
- Postal code
- 00976
- Report date
- Feb 8, 2023
- Product type
- Drugs
- Recall number
- D-0258-2023
- Classification
- Class II
- Recalling firm
- Frenda Corporation
- Product quantity
- 44,140 bottles
- Termination date
- Sep 10, 2024
- Reason for recall
- cGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Puerto Rico
- Recall initiation date
- Dec 15, 2022
- Initial firm notification
- Letter
- Center classification date
- Jan 30, 2023