Why it was recalled
Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.
Product description
DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, Original, 4FL OZ (118 ml) bottle, Hecho en Puerto Rico por: Omega & Delta Co., Inc. UPC 7 42699 00027 4
Lot numbers, UPCs & expiration codes
Lot #s 1327034, 1328034, 1277029, 1278029, 1202015, 1203015, 0246097, 0247097, 0247099, 0248099, 0252099
Where it was sold
Distributed in Puerto Rico only.
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-0103-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Oct 20, 2023
- FDA report date
- Nov 22, 2023
- Quantity
- 48,145 4 oz bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Omega & Delta Co., Inc.
Original FDA data
Every field from FDA enforcement report D-0103-2024, exactly as published.
Show all FDA fields
- City
- Carolina
- State
- PR
- Status
- Ongoing
- Country
- United States
- Event ID
- 93159
- Address
- Carr. 887 Km 0 Hm 8 Julio N. Matos Ind. Park Bldg#10
- Code information
- Lot #s 1327034, 1328034, 1277029, 1278029, 1202015, 1203015, 0246097, 0247097, 0247099, 0248099, 0252099
- Postal code
- 00985
- Report date
- Nov 22, 2023
- Product type
- Drugs
- Recall number
- D-0103-2024
- Classification
- Class II
- Recalling firm
- Omega & Delta Co., Inc.
- Product quantity
- 48,145 4 oz bottles
- Reason for recall
- Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, Original, 4FL OZ (118 ml) bottle, Hecho en Puerto Rico por: Omega & Delta Co., Inc. UPC 7 42699 00027 4
- Distribution pattern
- Distributed in Puerto Rico only.
- Recall initiation date
- Oct 20, 2023
- Initial firm notification
- Center classification date
- Nov 14, 2023