The Recall Desk
CriticalFDA (Drugs)·D-0882-2019·Announced 2019-03-20

King Bio Recalls Dr. King's SafeCare Rx Restless Mind Due to Microbial Contamination

King Bio Inc. is recalling Dr. King's SafeCare Rx Restless Mind because of microbial contamination. The product was distributed in the U.S., Canada, and Australia.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The recall is classified as FDA Class I, which meets the rubric criteria for a Critical severity score.

Plain-English summary

King Bio Inc. is recalling Dr. King's SafeCare Rx Restless Mind, a 2 fl. oz. (59 mL) product, due to microbial contamination. The recall involves 388 bottles with specific lot numbers and expiration dates ranging from September 2018 to December 2018.

The affected product was distributed nationwide in the United States, as well as in Canada and Australia. The recall is classified as Class I by the U.S. Food and Drug Administration.

Consumers should stop using the product and return it to the place of purchase or contact the manufacturer for instructions.

The recalled product

Product
Dr. King's SafeCare Rx Restless Mind, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955153023, NDC 57955-1531-2
Manufacturer
King Bio Inc.
Category
Drug — Topical
Hazard
Affected units
388

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: 091415A Exp. 09/18
  • 113015K Exp. 11/18
  • 122915A Exp. 12/18

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 →

Related recalls

Same manufacturer · King Bio Inc.

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Same hazard · microbial contamination

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