XZone 1200 Recalled for Undeclared Erectile Dysfunction Ingredients
Nova Products, Inc. is voluntarily recalling XZone 1200 capsules because FDA analysis found undeclared sildenafil and tadalafil.
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 agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric.
Plain-English summary
Nova Products, Inc. of Aston, Pennsylvania, is voluntarily recalling XZone 1200, 750 mg capsules. The product is distributed by Xzone in Orlando, Florida, and was marketed nationwide to retailers and distributors. The specific lot number is 13071012.
The recall is being conducted because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). FDA laboratory analysis determined that the capsules contain undeclared amounts of sildenafil and tadalafil. These are active ingredients used in FDA-approved drugs to treat erectile dysfunction.
Consumers who have purchased XZone 1200 should stop using the product and contact the distributor or retailer for further instructions.
The recalled product
- Product
- Xzone 1200, 750 mg, one capsule per blister pack, Distributed by: Xzone, Orlando, FL 32789
- Manufacturer
- Nova Products, Inc.
- Category
- Drug — Supplement
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)
- Lot# 13071012
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Nova Products, 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.
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