Beaumont Bio-Med Recalls Sore Throat Homeopathic Spray Due to CGMP Deviations
Beaumont Bio-Med is recalling Sore Throat & Laryngitis Response Homeopathic Formula due to manufacturing deviations that could result in 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 due to CGMP deviations and potential microbial contamination. Per the rubric, this falls under 'voluntary precautionary recalls' or 'low-risk contamination' where no specific illnesses or injuries are reported in the source text, distinguishing it from Class I (Critical) or high-risk pathogen scenarios (High).
Plain-English summary
Beaumont Bio-Med, Inc. is recalling 420 bottles of Sore Throat & Laryngitis 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 two specific lots: 100316G (Expiration 10/2019) and 050118R (Expiration 05/2021). The National Drug Code (NDC) for the product is 58066-7014-7.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The product was manufactured by a contract manufacturer under conditions that could result in possible microbial contamination. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers who have purchased this product should stop using it and contact Beaumont Bio-Med, Inc. for further instructions or a refund. The company is located in Waukon, IA 52172.
The recalled product
- Product
- Sore Throat & Laryngitis 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 58066-7014-7
- Manufacturer
- Beaumont Bio-med, Inc.
- Category
- Drug — Homeopathic
- Affected units
- 420
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: 100316G
- Exp 10/2019
- 050118R
- 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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