Man King Capsules Recalled for Unapproved Sildenafil Presence
The FDA is recalling Man King Capsules because they contain sildenafil, an unapproved active ingredient. Consumers should stop using the product.
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 per the rubric mandates a minimum score of 4 (Severe) due to the serious and temporary or life-threatening adverse health consequences associated with unapproved active ingredients.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling Man King Capsules, 2800 mg, boxes of 5 packets. The product was marketed without an approved Abbreviated New Drug Application (ANDA) or New Drug Application (NDA). The recall is due to the presence of sildenafil, an active pharmaceutical ingredient that was not approved for this over-the-counter product.
The recall involves 69 boxes of the product, which were distributed nationwide. The recall covers all lots of the product. The product was developed by American Wanbao Pharmaceutical International Group and Hainan Wanbao Biological Engineering Co., Ltd., and marketed by www.vitaminbestbuy.com.
Consumers who have purchased Man King Capsules should stop using the product immediately. The presence of sildenafil in an unapproved over-the-counter product poses a risk to consumer health, as the dosage and safety profile have not been evaluated for this specific formulation.
The recalled product
- Product
- Man King Capsules, 2800 mg, boxes of 5 packets, OTC, Developed by: American Wanbao Pharmaceutical International Group and Hainan Wanbao Biological Engineering Co., Ltd., 27 Heping Road, Haikou, Henan Province, UPC 9 009900 0032328
- Manufacturer
- www.vitaminbestbuy.com
- Affected units
- 69
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.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by www.vitaminbestbuy.com 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 3 products in this recall →Related recalls
Same manufacturer · www.vitaminbestbuy.com
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