The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-0867-2019·Announced 2019-03-20

King Bio Recalls Mental Alertness Drops Due to Microbial Contamination

King Bio Inc. is recalling Dr. King's SafeCare Rx Mental Alertness For Seniors 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 corresponds to a Critical severity score per the rubric.

Plain-English summary

King Bio Inc. is recalling 201 bottles of Dr. King's SafeCare Rx Mental Alertness For Seniors, 2 fl. oz. (59 mL). The recall is being conducted because the product is subject to microbial contamination.

The affected product is identified by NDC 57955-1561-2 and UPC 357955156024. The specific lots involved are 072815R (Expiration 07/18) and 090116D (Expiration 09/19). The recall number is D-0867-2019.

The product was distributed nationwide in the United States, as well as in Canada and Australia. Consumers should stop using the product and contact the manufacturer or their healthcare provider for further instructions.

The recalled product

Product
Dr. King's SafeCare Rx Mental Alertness For Seniors, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955156024, NDC 57955-1561-2
Manufacturer
King Bio Inc.
Category
Drug — OTC Drug
Hazard
Affected units
201

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: 072815R Exp. 07/18
  • 090116D Exp. 09/19

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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