The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-0687-2019·Announced 2019-03-20

King Bio Recalls Children's Ear Relief Due to Microbial Contamination

King Bio Inc. is recalling 45 bottles of Dr. King's SafeCare Rx Children's Ear Relief 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 recall is classified as FDA Class I, which per the rubric corresponds to a Critical severity score of 5.

Plain-English summary

King Bio Inc. is recalling 45 bottles of Dr. King's SafeCare Rx Children's Ear Relief Children High Potency Homeopathic Formula for Professional Use Only, 2 fl. oz. (59 mL). The recall was initiated due to microbial contamination.

The affected product is identified by Lot 032316B with an expiration date of 03/19. The product was distributed nationwide in the United States, as well as in Canada and Australia.

Consumers should stop using the product and contact King Bio Inc. for further instructions or a refund. The recall is classified as FDA 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 SafeCare Rx Children's Ear Relief Children High Potency Homeopathic Formula for Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955075721, NDC 57955-0758-2
Manufacturer
King Bio Inc.
Category
Drug — Homeopathic
Hazard
Affected units
45

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 (1)

  • Lots: 032316B Exp. 03/19

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.

See all 465 products in this recall →

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