Why it was recalled
Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.
Product description
Advanced Protection Sunscreen spf 30 (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5 Oz/127.5 g tube.
Lot numbers, UPCs & expiration codes
Lot #: 131965, Exp 12/2018; 127426 Exp. 01/2019; 129045, 130424 Exp. 06/2019; 130432 Exp. 10/2019; 131870 Exp. 06/2019; 132648, Exp. 03/2020; 133732 Exp. 04/2020; 134400 Exp. 02/2020; 135345 Exp. 08/2020
Where it was sold
United States, Maldives, Canada, United Arab Emirates, and New Zealand
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-0341-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 10, 2018
- FDA report date
- Dec 26, 2018
- Quantity
- 5363 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- CBI Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0341-2019, exactly as published.
Show all FDA fields
- City
- Fort Worth
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 81775
- Address
- 4201 Diplomacy Rd
- Code information
- Lot #: 131965, Exp 12/2018; 127426 Exp. 01/2019; 129045, 130424 Exp. 06/2019; 130432 Exp. 10/2019; 131870 Exp. 06/2019; 132648, Exp. 03/2020; 133732 Exp. 04/2020; 134400 Exp. 02/2020; 135345 Exp. 08/2020
- Postal code
- 76155-2633
- Report date
- Dec 26, 2018
- Product type
- Drugs
- Recall number
- D-0341-2019
- Classification
- Class III
- Recalling firm
- CBI Laboratories, Inc.
- Product quantity
- 5363 tubes
- Termination date
- Jan 14, 2020
- Reason for recall
- Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Advanced Protection Sunscreen spf 30 (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5 Oz/127.5 g tube.
- Distribution pattern
- United States, Maldives, Canada, United Arab Emirates, and New Zealand
- Recall initiation date
- Dec 10, 2018
- Initial firm notification
- Letter
- Center classification date
- Dec 20, 2018