The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-0524-2019·Announced 2019-03-20

King Bio Homeopathic Allergy Product Recalled for Microbial Contamination

King Bio Inc. is recalling Dr. King's Natural Medicine Homeopathic Regional Allergies Northeastern U.S. 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 corresponds to a Critical severity score of 5 according to the rubric.

Plain-English summary

King Bio Inc. is voluntarily recalling 3,651 bottles of Dr. King's Natural Medicine Homeopathic Regional Allergies Northeastern U.S., 2 fl. oz. (59 mL). The recall was initiated because the product is subject to microbial contamination.

The affected product is identified by NDC 57955-0753-2 and UPC 357955519225. Specific lot numbers and expiration dates include 030817M (Exp. 03/19), 050216E (Exp. 05/19), 070816D (Exp. 07/19), 010118D (Exp. 01/20), and 030418B (Exp. 03/20). The 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 U.S. Food and Drug Administration 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 Regional Allergies Northeastern U.S., 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955519225, NDC 57955-0753-2
Manufacturer
King Bio Inc.
Category
Drug — Homeopathic Medicine
Hazard
Affected units
3,651

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 (5)

  • Lot Numbers: 030817M Exp. 03/19
  • 050216E Exp. 05/19
  • 070816D Exp. 07/19
  • 010118D Exp. 01/20
  • 030418B Exp. 03/20

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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