The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-0636-2019·Announced 2019-03-20

King Bio Recalls Homeopathic Ear Ringing Product Due to Microbial Contamination

King Bio Inc. is recalling Dr. King's Natural Medicine Homeopathic Ear Ringing 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 meets the rubric criteria for a Critical severity score.

Plain-English summary

King Bio Inc. is recalling 1,980 bottles of Dr. King's Natural Medicine Homeopathic Ear Ringing, 2 fl. oz. (59 mL). The recall is due to microbial contamination. The affected product has NDC 57955-5275-2 and UPC 357955527527.

The recalled product was distributed nationwide in the United States, as well as in Canada and Australia. The specific lots involved are 052516V (expiration date 05/19) and 052517E (expiration date 05/20).

Consumers should check their home medicine cabinets for this product and stop using it if they have it. The FDA has classified this recall as Class I, which is the most serious type of recall.

The recalled product

Product
Dr. King's Natural Medicine Homeopathic Ear Ringing, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955527527, NDC 57955-5275-2
Manufacturer
King Bio Inc.
Category
Drug — Homeopathic
Hazard
Affected units
1,980

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)

  • Lots: 052516V Exp. 05/19
  • 052517E Exp. 05/20

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.

See all 465 products in this recall →

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