The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-0984-2019·Announced 2019-03-20

King Bio Recalls Homeopathic Formula Due to Microbial Contamination

King Bio Inc. is recalling Dr. King's SafeCare Rx Aversion to Change Homeopathic 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 indicates a reasonable probability that use of or exposure to the violative product will cause serious adverse health consequences or death.

Plain-English summary

King Bio Inc. is recalling 48 bottles of Dr. King's SafeCare Rx Aversion to Change High Potency Homeopathic Formula for Professional Use Only, 2 fl oz (59 mL). The recall is due to microbial contamination. The affected product is identified by NDC 57955-2800-2 and UPC 357955280026.

The recalled lots include 072015H (Exp. 07/18), 111016E (Exp. 11/19), and 011917N (Exp. 01/20). The product was distributed nationwide in the United States, as well as in Canada and Australia.

Consumers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the point of purchase or disposed of according to local regulations. The FDA has classified this recall as Class I.

The recalled product

Product
Dr. King's SafeCare Rx Aversion to Change High Potency Homeopathic Formula for Professional Use Only, 2 fl oz (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955280026, NDC 57955-2800-2
Manufacturer
King Bio Inc.
Category
Drug — Homeopathic
Hazard
Affected units
48

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 (3)

  • Lots: 072015H Exp. 07/18
  • 111016E Exp. 11/19
  • 011917N Exp. 01/20

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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