Status
Terminated
Drug Enforcement D-1670-2012
Microbial Contamination of Non Sterile Product; mold
Classification
Class II
Report Date
September 5, 2012
Termination Date
September 18, 2013
Product Information
- 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.
- Product quantity
- 5311 bottles
- Reason for recall
- Microbial Contamination of Non Sterile Product; mold
- Recall initiation reason
- —
- Initial firm notification
- Distribution pattern
- Atlanta, Georgia
Location & Firm
- Recalling firm
- Island Kinetics dba Covalence
- Address
-
460 S Benson Ln Ste 3, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1670-2012
- Event ID
- 62779
- Recall initiation date
- July 13, 2012
- Center classification date
- August 29, 2012
- Code info
- Batch # P030911C, Exp 03/13; Batch # P022811A, Exp 02/13.
- More code info
- —