Beaumont Bio-Med Recalls Arthritis Pain Relief Spray Due to CGMP Deviations
Beaumont Bio-Med is recalling 140 bottles of Arthritis Pain Relief Homeopathic Formula due to manufacturing conditions 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 and involves a theoretical risk of microbial contamination without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Beaumont Bio-Med, Inc. is recalling 140 bottles of Arthritis Pain Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle. The product is identified by NDC 58066-7042-7, Lot 012916E, and an expiration date of 01/2019.
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 agency has classified this recall as Class II.
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
- Arthritis Pain 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 58066-7042-7
- Manufacturer
- Beaumont Bio-med, Inc.
- Category
- Drug — Homeopathic
- Hazard
- Affected units
- 140
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: 012916E
- Exp 01/2019
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.
See all 8 products in this recall →Related recalls
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