Sunset Natural Products Recalls Prostax Forte Dietary Supplement
Sunset Natural Products Inc. is recalling Prostax Forte dietary supplements pursuant to a consent decree requiring the destruction of products manufactured since April 2014.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a reasonable probability of temporary or medically reversible health consequences. The source text does not report specific illnesses or injuries, aligning with a moderate severity rating for a regulatory compliance recall.
Plain-English summary
Sunset Natural Products Inc. is recalling Prostax Forte, a dietary supplement, pursuant to a consent decree with the U.S. Food and Drug Administration. The recall covers products manufactured, prepared, processed, packed, labeled, held, and/or distributed between April 2, 2014, and the date the decree was entered on September 25, 2015. Known lots include Lot # 300614 (Exp. 06/17) and Lot # 480614 (Exp. 10/17).
The consent decree prohibits the company and its owners from marketing dietary supplements until they recall and destroy the affected products under FDA supervision, hire a cGMP expert, and receive written permission from the FDA to resume operations. The source text does not specify a particular health hazard, illness, or injury associated with this recall.
Products were distributed to Florida, Nevada, and the Dominican Republic. Consumers who have purchased these products should stop using them and follow the instructions provided by the recalling firm or the FDA regarding disposal or return.
The recalled product
- Product
- Prostax Forte, (50,000 capsule bulk)
- Manufacturer
- Sunset Natural Products Inc.
- Category
- Food — Dietary Supplement
- Affected units
- 100,000
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 (12)
- As persuant to the Consent Decree
- the firm agreed to "recall and destroy
- under FDA's supervision
- in accordance with the procedures provided in paragraph 6
- ALL dietary supplements that were manufactured
- prepared
- processed
- packed
- labeled
- held and/or distributed between April 2
- 2015. Known lots and expiration dates: Lot # 300614 Exp. Date 06/17
- Lot # 480614 Exp. Date 10/17
Distribution
Part of a larger recall action
This product is one of 163 recalled by Sunset Natural Products Inc. under a single FDA (Food) 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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