Beaumont Bio-Med Recalls Allergy & Hay Fever Relief Homeopathic Formula
Beaumont Bio-Med is recalling 124 bottles of Allergy & Hay Fever Relief Homeopathic Formula due to CGMP 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 possible microbial contamination without reporting specific illnesses or injuries, aligning with the criteria for moderate severity.
Plain-English summary
Beaumont Bio-Med, Inc. is recalling 124 bottles of Allergy & Hay Fever Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle. The product is identified by NDC 58066-7011-7, Lot 050216X, and an expiration date of 05/2019.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The products were manufactured by a contract manufacturer under conditions that could result in possible microbial contamination.
The affected product was distributed nationwide in the USA. Consumers should stop using the product and contact the recalling firm for further instructions.
The recalled product
- Product
- Allergy & Hay Fever Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7011-7
- Manufacturer
- Beaumont Bio-med, Inc.
- Category
- Drug — Homeopathic
- Hazard
- Affected units
- 124
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 (2)
- Lot: 050216X
- Exp 05/2019
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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