Washington Homeopathic Products Recalls R2103 Due to Manufacturing Deviations
Washington Homeopathic Products, Inc. is recalling R2103 homeopathic product because it was not manufactured under current good manufacturing practices.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
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, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Washington Homeopathic Products, Inc. is recalling R2103, a homeopathic product containing Berberis Aquifolium 3x, Borax 3, Kreosotum 10X, and Sepia 3x. The product is packaged in 470 mL and 1000 mL bottles and was manufactured for Wisconsin Pharmacal Company.
The recall was initiated because the products were not manufactured under current good manufacturing practices (CGMP). The affected lot number is 28557. The product was distributed nationwide in the United States, as well as in Canada and Saudi Arabia.
Consumers who have this product should stop using it and contact the recalling firm for further instructions.
The recalled product
- Product
- R2103, Active Ingredients: Berberis Aquifolium 3x; Borax 3; , Kreosotum 10X; Sepia 3x. Inactive ingredient: 28% dilution alcohol, packaged in a) 470 mL bottle and b) 1000 mL bottle; Manufactured for Wisconsin Pharmacal Company, By: Washington Homeopathic Products, Inc., 260 JR…
- Manufacturer
- Washington Homeopathic Products, Inc.
- Category
- Drug — Homeopathic
- Hazard
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 #: 28557
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 16 recalled by Washington Homeopathic 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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