King Bio Recalls Homeopathic Teeth and Gums Formula Due to Microbial Contamination
King Bio Inc. is recalling Dr. King's Natural Medicine Homeopathic Teeth & Gums Formula due to microbial contamination. The product was distributed in the U.S., Canada, and Australia.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA has classified this recall as Class I, which per the rubric mandates a severity score of 5 (Critical) due to the reasonable probability of serious adverse health consequences.
Plain-English summary
King Bio Inc. is recalling 2,225 bottles of Dr. King's Natural Medicine Homeopathic Teeth & Gums Formula, 2 fl. oz. (59 mL). The recall is due to microbial contamination. The product is identified by NDC 57955-5073-2 and UPC 357955507321.
The affected lots include 010517E (Exp. 01/20), 010518A (Exp. 01/20), 022417C (Exp. 02/20), 052516H (Exp. 05/19), 091616D (Exp. 09/19), and 112016A (Exp. 11/19). The product was distributed nationwide in the U.S.A., as well as in Canada and Australia.
Consumers should stop using the product and check their lot numbers against the list provided. The FDA has classified this as a Class I recall, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.
The recalled product
- Product
- Dr. King's Natural Medicine Homeopathic Teeth & Gums Formula, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955507321, NDC 57955-5073-2
- Manufacturer
- King Bio Inc.
- Category
- Drug — Homeopathic Medicine
- Hazard
- Affected units
- 2,225
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 (6)
- Lot Numbers: 010517E Exp. 01/20
- 010518A Exp. 01/20
- 022417C Exp. 02/20
- 052516H Exp. 05/19
- 091616D Exp. 09/19
- 112016A Exp. 11/19
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 465 recalled by King Bio 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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