Why it was recalled
Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.
Product description
Well at Walgreens, Scar Cream with SPF 30, (Avobenzone 3%, Octocrylene 10%, Oxybenzone 6%), 0.7 OZ (19.8 g) tube, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, UPC 3 11917 18281 0.
Lot numbers, UPCs & expiration codes
Lot: 163241K, Exp. October 2018
Where it was sold
Nationwide in the USA
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-0069-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 3, 2018
- FDA report date
- Oct 24, 2018
- Quantity
- 6,516 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Product Quest Manufacturing LLC
Original FDA data
Every field from FDA enforcement report D-0069-2019, exactly as published.
Show all FDA fields
- City
- Daytona Beach
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 80750
- Address
- 330 Carswell Ave
- Code information
- Lot: 163241K, Exp. October 2018
- Postal code
- 32117-4416
- Report date
- Oct 24, 2018
- Product type
- Drugs
- Recall number
- D-0069-2019
- Classification
- Class III
- Recalling firm
- Product Quest Manufacturing LLC
- Product quantity
- 6,516 tubes
- Termination date
- Mar 30, 2021
- Reason for recall
- Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Well at Walgreens, Scar Cream with SPF 30, (Avobenzone 3%, Octocrylene 10%, Oxybenzone 6%), 0.7 OZ (19.8 g) tube, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, UPC 3 11917 18281 0.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Aug 3, 2018
- Initial firm notification
- Letter
- Center classification date
- Oct 16, 2018