King Bio Recalls Homeopathic Ear Relief Formula Due to Microbial Contamination
King Bio Inc. is recalling Dr. King's Natural Medicine Homeopathic Ear Relief 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 agency classification is FDA Class I, which per the rubric mandates a severity score of 5 (Critical) regardless of other factors.
Plain-English summary
King Bio Inc. is recalling 425 bottles of Dr. King's Natural Medicine Homeopathic Ear Relief Formula, 2 fl. oz. (59 mL), due to microbial contamination. The product is identified by NDC 57955-0918-2 and UPC 357955515722.
The recall covers two specific lot numbers: 032816B with an expiration date of 03/19, and 101917B with an expiration date of 10/19. The affected product was distributed nationwide in the United States, as well as in Canada and Australia.
Consumers who have purchased this product should stop using it and contact King Bio Inc. for further instructions or a refund. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product may cause serious adverse health consequences or death.
The recalled product
- Product
- Dr. King's Natural Medicine Homeopathic Ear Relief Formula, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955515722, NDC 57955-0918-2
- Manufacturer
- King Bio Inc.
- Category
- Drug — Homeopathic Medicine
- Hazard
- Affected units
- 425
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 Numbers: 032816B Exp. 03/19
- 101917B Exp. 10/19
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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