Drug product
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.
D-1670-2012
Product summary
- Event
- Event 62779
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5311 bottles
- Official record key
drug-enforcement:D-1670-2012
Official wording
Reason: Microbial Contamination of Non Sterile Product; mold
Code information: Batch # P030911C, Exp 03/13; Batch # P022811A, Exp 02/13.
Distribution pattern: Atlanta, Georgia
Derived failure modes
-
Microbial contamination
Microbial Contamination