Beaumont Bio-Med Recalls Diarrhea Response Homeopathic Formula Due to CGMP Deviations
Beaumont Bio-Med, Inc. is recalling 160 bottles of Diarrhea Response Homeopathic Formula due to manufacturing deviations that could result in microbial contamination.
What this means for you
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 160 bottles of Diarrhea Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle. The product is identified by NDC 58066-7022-7, Lot 090915A, and an expiration date of 09/2018. The recall was initiated because the product was 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 have this product should stop using it and contact the recalling firm for further instructions.
The recalled product
- Product
- Diarrhea 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 58066-7022-7
- Manufacturer
- Beaumont Bio-med, Inc.
- Category
- Drug — Homeopathic
- Hazard
- Affected units
- 160
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: 090915A
- Exp 09/2018
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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