The Recall Desk
ModerateFDA (Drugs)·D-1194-2018·Announced 2018-09-26

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.

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 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
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.

See all 8 products in this recall →