Beaumont Bio-Med Recalls Colds & Flu Response Homeopathic Formula
Beaumont Bio-Med is recalling Colds & Flu Response Homeopathic Formula due to potential microbial contamination from manufacturing deviations.
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 'possible microbial contamination' without reporting any specific illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Beaumont Bio-Med, Inc. is recalling 314 bottles of Colds & Flu Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle. The product is distributed nationwide in the USA. The recall involves specific lots: 042816C (Exp 04/2019) and 112317K (Exp 11/2020), identified by NDC 58066-7012-7.
The recall was initiated because the product was manufactured by a contract manufacturer under conditions that resulted in Current Good Manufacturing Practice (CGMP) deviations. These deviations could result in possible microbial contamination.
Consumers who have purchased this product should check their lot numbers and expiration dates against the recalled items. If the product matches the recalled lots, consumers should stop using it and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Colds & Flu 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 58066-7012-7
- Manufacturer
- Beaumont Bio-med, Inc.
- Category
- Drug — Homeopathic
- Hazard
- Affected units
- 314
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: 042816C
- Exp 04/2019
- 112317K
- Exp 11/2020
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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