Why it was recalled
Microbial Contamination of Non Sterile Product; mold
Product description
CosMedix Serious Protection, Natural SPF 28 Sunscreen, 3.3 fl.oz/100mL (100 g), Distributed by CosMedix, LLC, Atlanta, GA --- Also labeled as RESULTS RX, Serious Protection Rx, SPF 28 Sunscreen, Net Wt. 4oz/120g.
Lot numbers, UPCs & expiration codes
Batch # P030911C, Exp 03/13; Batch # P022811A, Exp 02/13.
Where it was sold
Atlanta, Georgia
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-1670-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 13, 2012
- FDA report date
- Sep 5, 2012
- Quantity
- 5311 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Island Kinetics dba Covalence
Original FDA data
Every field from FDA enforcement report D-1670-2012, exactly as published.
Show all FDA fields
- City
- Chandler
- State
- AZ
- Status
- Terminated
- Country
- United States
- Event ID
- 62779
- Address
- 460 S Benson Ln Ste 3
- Code information
- Batch # P030911C, Exp 03/13; Batch # P022811A, Exp 02/13.
- Postal code
- 85224-5663
- Report date
- Sep 5, 2012
- Product type
- Drugs
- Recall number
- D-1670-2012
- Classification
- Class II
- Recalling firm
- Island Kinetics dba Covalence
- Product quantity
- 5311 bottles
- Termination date
- Sep 18, 2013
- Reason for recall
- Microbial Contamination of Non Sterile Product; mold
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- CosMedix Serious Protection, Natural SPF 28 Sunscreen, 3.3 fl.oz/100mL (100 g), Distributed by CosMedix, LLC, Atlanta, GA --- Also labeled as RESULTS RX, Serious Protection Rx, SPF 28 Sunscreen, Net Wt. 4oz/120g.
- Distribution pattern
- Atlanta, Georgia
- Recall initiation date
- Jul 13, 2012
- Initial firm notification
- Center classification date
- Aug 29, 2012