maXXzen Platinum 12000 Capsule Recalled for Undisclosed Drug Contaminants
The FDA is recalling maXXzen Platinum 12000 capsules distributed nationwide because the product was marketed without an approved application and contains undisclosed pharmaceutical ingredients (Sildenafil and Tadalafil).
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: This is an FDA Class I recall for an unapproved drug product containing undisclosed pharmaceutical agents (Sildenafil and Tadalafil). Class I recalls meet the threshold for Severe (score 4) per the rubric, as they represent serious public health hazards.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling maXXzen Platinum 12000 capsule, 1-count blister card (UPC 7 18122 04072 8), manufactured by Miracle 8989 and distributed by Maxx Inc, Los Angeles, CA 90028.
The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Upon inspection, the product was found to be tainted with Sildenafil and Tadalafil, active pharmaceutical ingredients not declared on the product labeling.
This product was distributed nationwide in the United States. All lots remaining within expiration date are subject to this recall.
Consumers who have purchased this product should stop use immediately. Those with questions about this recall should contact the FDA or the recalling firm.
The recalled product
- Product
- maXXzen Platinum 12000 capsule, 1-count blister card (UPC 7 18122 04072 8), Distributed by: Maxx Inc, Los Angeles, CA 90028
- Manufacturer
- Miracle 8989
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 3 recalled by Miracle 8989 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
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