The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-0985-2019·Announced 2019-03-20

FDA Recalls King Bio Homeopathic Breast Cyst Formula for Microbial Contamination

King Bio Inc. is recalling Dr. King's SafeCare Rx Breast Cyst & Discomforts 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 source text explicitly identifies the agency classification as 'Class I' and the hazard as 'Microbial contamination.' Per the rubric, an FDA Class I recall mandates a severity score of 5 (Critical).

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class I recall for Dr. King's SafeCare Rx Breast Cyst & Discomforts High Potency Homeopathic Formula for Professional Use Only. The recall is being conducted by King Bio Inc. because the product is subject to microbial contamination.

The affected product is a 2 fl oz (59 mL) bottle with NDC 57955-0003-2 and UPC 357955000327. The recall covers 162 bottles from two specific lots: Lot 040616B (Expiration 04/19) and Lot 020917G (Expiration 02/20). The product was distributed nationwide in the United States, as well as in Canada and Australia.

Consumers and healthcare professionals should stop using the product immediately and return it to the point of purchase or contact King Bio Inc. for further instructions. The FDA classifies this as a Class I recall, which is the most serious type of recall, 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 Breast Cyst & Discomforts High Potency Homeopathic Formula for Professional Use Only, 2 fl oz (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955000327, NDC 57955-0003-2
Manufacturer
King Bio Inc.
Category
Drug — Homeopathic
Hazard
Affected units
162

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: 040616B Exp. 04/19
  • 020917G Exp. 02/20

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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