The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-0684-2019·Announced 2019-03-20

King Bio Recalls Children's Homeopathic Formula Due to Microbial Contamination

King Bio Inc. is recalling specific lots of Dr. King's SafeCare Rx Children's Growth & Development homeopathic formula due to microbial contamination.

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 mandates a severity score of 5 according to the rubric.

Plain-English summary

King Bio Inc. is recalling 98 bottles of Dr. King's SafeCare Rx Children's Growth & Development Children High Potency Homeopathic Formula for Professional Use Only. The recall affects 2 fl. oz. (59 mL) bottles with NDC 57955-0148-2 and UPC 357955014225.

The recall was initiated due to microbial contamination. The affected lots are 020917A (Expiration 02/2020) and 062716E (Expiration 06/2019). The product was distributed nationwide in the U.S.A., 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 recalled product

Product
Dr. King's SafeCare Rx Children's Growth & Development 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 357955014225, NDC 57955-0148-2
Manufacturer
King Bio Inc.
Affected units
98

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: 020917A Exp. 02/2020
  • 062716E Exp. 06/2019

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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