D-1670-2012 Class II Terminated
FDA drug recall D-1670-2012 was initiated by Island Kinetics dba Covalence on July 13, 2012 and is designated Class II. Reason for recall: Microbial Contamination of Non Sterile Product; mold The recall status is terminated (terminated September 18, 2013). Affected quantity: 5311 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- September 5, 2012
- Initiation Date
- July 13, 2012
- Termination Date
- September 18, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5311 bottles
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.
Reason for Recall
Microbial Contamination of Non Sterile Product; mold
Distribution Pattern
Atlanta, Georgia
Code Information
Batch # P030911C, Exp 03/13; Batch # P022811A, Exp 02/13.