The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-0844-2019·Announced 2019-03-20

King Bio Recalls Dr. King's SafeCare Rx Teeth & Gum Formula

King Bio Inc. is recalling Dr. King's SafeCare Rx Teeth & Gum 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 agency classification is FDA Class I, which is defined as a situation where use of or exposure to a violative product may cause serious adverse health consequences or death. Per the rubric, FDA Class I recalls are assigned a score of 5.

Plain-English summary

King Bio Inc. is recalling 492 bottles of Dr. King's SafeCare Rx Teeth & Gum Formula, 2 fl. oz. (59 mL), due to microbial contamination. The affected product is identified by NDC 57955-0073-2 and UPC 357955007326.

The recall covers specific lots with the following expiration dates: 06/18 (Lot 062415E), 07/18 (Lot 071116D), and 12/19 (Lot 121317H). The product was distributed nationwide in the United States, as well as in Canada and Australia.

Consumers should check their inventory for the specific lot numbers and expiration dates listed above. If they possess the affected product, they should stop using it and contact King Bio Inc. for further instructions.

The recalled product

Product
Dr. King's SafeCare Rx Teeth & Gum Formula, 2 fl. oz. (59 mL), NDC 57955-0073-2 UPC 357955007326 King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA
Manufacturer
King Bio Inc.
Category
Drug — Dental
Hazard
Affected units
492

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: 062415E Exp. 06/18
  • 071116D Exp. 07/18
  • 121317H Exp. 12/19

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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