Class II · Moderate risk
Blemish Spot Treatment
Failed Stability Specifications
CosMedix Serious Protection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Microbial Contamination of Non Sterile Product; mold
Cause type: Microbial contamination
Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection. All microbial contamination recalls.
What was recalled
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.
- Recalling firm
- Island Kinetics dba Covalence
- Origin
- AZ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1670-2012 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Island Kinetics dba Covalence
All 2012 recalls
Class III · Low risk
Essential Calming Skin Gel
Subpotent Drug
Class III · Low risk
Skin Rehab
Subpotent Drug
Class III · Low risk
Remedy Gel
Subpotent Drug
Other microbial contamination recalls from 2012
All microbial contamination recalls
Class II · Moderate risk
Hillyard
Microbial Contamination of Non-Sterile Products: The product may be contaminated with bacteria.
Class II · Moderate risk
12-Hour Sinus
Microbial Contamination of a Non-Sterile Products: 12-Hour Sinus Nasal Spray under various labeling are being recalled due to microbial contamination identified during testing.
Class I · High risk
Zicam Extreme Congestion Relief
Microbial Contamination of Non-Sterile Products: Product may be contaminated with Burkholderia cepacia.
Class II · Moderate risk
NorthStar Arthritis Relief Cream. Net Wt. 2 oz tube
Microbial Contamination of Non-Sterile Products: Arthritis Relief Cream failed microbiological specifications.
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