CosMedix Serious Protection — Class II drug recall D-1670-2012
Terminated recall by Island Kinetics dba Covalence, reported 2012-09-05, distributed in GA. Microbial Contamination of Non Sterile Product; mold
| Recall number | D-1670-2012 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Island Kinetics dba Covalence, Chandler, AZ, United States |
| Recall initiated | 2012-07-13 |
| Classified | 2012-08-29 |
| Reported by FDA | 2012-09-05 |
| Terminated | 2013-09-18 |
| Distributed | GA |
| Quantity | 5,311 bottles |
| Reason classes | microbial contamination, sterility |
| Pathogens | mold |
| Lot numbers | 02/13, 03/13, P022811A, P030911C |
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.
Reason for recall
Microbial Contamination of Non Sterile Product; mold
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1670-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.