CosMedix Sunscreen Recalled for Microbial Contamination and Mold
Island Kinetics is recalling CosMedix Serious Protection SPF 28 Sunscreen due to microbial contamination and mold. Consumers should stop using the product.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant contamination like mold in a product applied to the skin.
Plain-English summary
Island Kinetics dba Covalence is recalling 5,311 bottles of CosMedix Serious Protection, Natural SPF 28 Sunscreen. The product is also labeled as RESULTS RX, Serious Protection Rx, SPF 28 Sunscreen. The recall was initiated because the non-sterile product was found to be contaminated with microorganisms and mold.
The affected units are distributed in Atlanta, Georgia. The recall covers specific batches: Batch # P030911C with an expiration date of 03/13, and Batch # P022811A with an expiration date of 02/13. The product is available in 3.3 fl.oz/100mL (100 g) and 4oz/120g sizes.
Consumers who have purchased this product should stop using it immediately. The FDA has classified this recall as Class II, indicating that use of the product could cause temporary or medically reversible health problems.
The recalled product
- 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.
- Manufacturer
- Island Kinetics dba Covalence
- Category
- Drug — Topical Sunscreen
- Affected units
- 5,311
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Batch # P030911C
- Exp 03/13
- Batch # P022811A
- Exp 02/13.
Distribution
Distributed in 1 state:
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