Volcano Male Enhancement Liquid Recalled for Undeclared Pharmaceutical Ingredients
Myson Corporation is recalling Volcano Male Enhancement Liquid because it contains undeclared active pharmaceutical ingredients, making it an unapproved new drug.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of at least 4 per the rubric.
Plain-English summary
Myson Corporation, Inc. is recalling Volcano Male Enhancement Liquid, 2 FL OZ (60 ml) bottles, distributed by Volcano in Long Beach, CA. The recall covers all lots, including lot 0312-K2 with an expiration date of 11/14. The product was marketed as a dietary supplement but was found to contain undeclared active pharmaceutical ingredients.
The FDA has classified this recall as Class I because the presence of undeclared active pharmaceutical ingredients makes the product an unapproved new drug. The recall is nationwide, affecting 70 bottles. The product is identified by UPC 6 09613 85996 0 and is available at www.volcanoenhancement.com.
Consumers who have purchased Volcano Male Enhancement Liquid should stop using the product and return it to the place of purchase for a refund or contact the recalling firm for further instructions. The recall is being conducted to ensure the safety of consumers who may have been exposed to unapproved drug ingredients.
The recalled product
- Product
- Volcano Male Enhancement Liquid, 2 FL OZ (60 ml) bottle, www.volcanoenhancement.com, DISTRIBUTED BY VOLCANO Long Beach, CA 90813, UPC 6 09613 85996 0.
- Manufacturer
- Myson Corporation, Inc.
- Category
- Drug — Dietary Supplement
- Affected units
- 70
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 (2)
- All lots including 0312-K2
- Exp 11/14
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Myson Corporation, Inc. 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.
See all 2 products in this recall →Related recalls
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