Why it was recalled
CGMP Deviations
Product description
Omeza Skin Protectant, Skin Protectant Gel 10*2mL Vials
Lot numbers, UPCs & expiration codes
Lot: 19123 4-1, Exp. 05/11/2024
Where it was sold
US Nationwide
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-0289-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 19, 2024
- FDA report date
- Feb 14, 2024
- Quantity
- 1210 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- OMEZA LLC
Original FDA data
Every field from FDA enforcement report D-0289-2024, exactly as published.
Show all FDA fields
- City
- Sarasota
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 93847
- Address
- 1610 Northgate Blvd
- Code information
- Lot: 19123 4-1, Exp. 05/11/2024
- Postal code
- 34234-2114
- Report date
- Feb 14, 2024
- Product type
- Drugs
- Recall number
- D-0289-2024
- Classification
- Class II
- Recalling firm
- OMEZA LLC
- Product quantity
- 1210 vials
- Termination date
- Oct 17, 2024
- Reason for recall
- CGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Omeza Skin Protectant, Skin Protectant Gel 10*2mL Vials
- Distribution pattern
- US Nationwide
- Recall initiation date
- Jan 19, 2024
- Initial firm notification
- Center classification date
- Feb 4, 2024