Beaumont Bio-Med Recalls Skin Irritation Homeopathic Spray Due to CGMP Deviations
Beaumont Bio-Med is recalling Skin Irritation & Itch Response Homeopathic Formula due to manufacturing deviations that could result in possible microbial contamination.
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 describes a theoretical risk of microbial contamination without reporting any specific illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Beaumont Bio-Med, Inc. is recalling 192 bottles of Skin Irritation & Itch Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle. The product is identified by NDC 58066-7002-7 and includes Lot 091515C (Exp 09/2018) and Lot 050118S (Exp 05/2021). The recall was initiated because the products were manufactured by a contract manufacturer under conditions that deviated from Current Good Manufacturing Practices (CGMP), which could result in possible microbial contamination.
The affected product was distributed nationwide in the USA. Consumers who possess this product should stop using it and contact the recalling firm for further instructions or a refund.
The recalled product
- Product
- Skin Irritation & Itch Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7002-7
- Manufacturer
- Beaumont Bio-med, Inc.
- Category
- Drug — Homeopathic
- Affected units
- 192
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 (4)
- Lot: 091515C
- Exp 09/2018
- 050118S
- Exp 05/2021
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Beaumont Bio-med, 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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