Phillips Co. Recalls StingMed Insect Bites Skin Protectant Due to GMP Deviations
Phillips Co. is recalling StingMed Insect Bites Skin Protectant because FDA inspections found significant manufacturing deviations that raise questions about the product's safety and quality.
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 source text explicitly states the agency classification is Class II. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when the text indicates significant manufacturing issues that call into question the safety and quality of the product.
Plain-English summary
Phillips Co. is recalling StingMed Insect Bites Skin Protectant, a zinc acetate product used for insect bites. The recall involves 20 to 50 bottles of the 0.3 fl. oz. (3 mL) size, identified by NDC 04307-100-11. The affected units are all lots remaining within their expiration dates.
The recall was initiated following an FDA inspection that identified significant Good Manufacturing Practice (GMP) deviations. These findings call into question the safety, identity, strength, quality, and purity of the unexpired drug products manufactured by the firm. The agency has classified this recall as Class II.
The product was distributed nationwide and in the United Kingdom. Consumers who possess this product should stop using it and contact Phillips Co. for further instructions or a refund.
The recalled product
- Product
- StingMed Insect bites Skin Protectant. Zinc acetate (.1% by volume), 0.3 fl. oz. (3 mL) bottle, Phillips Company, Millerton, OK -- NDC 04307-100-11
- Manufacturer
- Phillips Co.
- Category
- Drug — Topical OTC
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 (1)
- All lots remaining within expiry.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Phillips Co. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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