The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-0677-2019·Announced 2019-03-20

King Bio Recalls Homeopathic Formula Due to Microbial Contamination

King Bio Inc. is recalling Dr. King's SafeCare Rx Attention & Learning Enhancement Children 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this recall as Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. Per the rubric, FDA Class I recalls are assigned a severity score of 4 or higher.

Plain-English summary

King Bio Inc. is recalling 336 bottles of Dr. King's SafeCare Rx Attention & Learning Enhancement Children High Potency Homeopathic Formula for Professional Use Only. The product is a 2 fl. oz. (59 mL) liquid formula manufactured by King Bio Inc. in Asheville, North Carolina.

The recall was initiated due to microbial contamination. The affected lots are 032316C (Exp. 03/2019), 091216A (Exp. 09/2019), and 121617A (Exp. 12/2019). The product was distributed nationwide in the U.S.A., as well as in Canada and Australia.

Consumers who have purchased this product should check their lot numbers and expiration dates against the information provided. If the product matches the recalled lots, consumers should stop using it and contact King Bio Inc. for further instructions.

The recalled product

Product
Dr. King's SafeCare Rx Attention & Learning Enhancement 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 357955001522, NDC 57955-0015-2
Manufacturer
King Bio Inc.
Category
Drug — Homeopathic
Hazard
Affected units
336

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: 032316C Exp. 03/2019
  • 091216A Exp. 09/2019
  • 121617A Exp. 12/2019

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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