The Recall Desk
CriticalFDA (Drugs)·D-0737-2019·Announced 2019-03-20

King Bio Recalls Dr. King's SafeCare Rx Sleep Aid Due to Microbial Contamination

King Bio Inc. is recalling Dr. King's SafeCare Rx Sleep Aid due to 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 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 1,244 bottles of Dr. King's SafeCare Rx Sleep Aid, 2 fl. oz. (59 mL), due to microbial contamination. The product is identified by NDC 57955-2640-2 and UPC 357955263920.

The affected lots are 022318F (Exp. 02/20), 020416A (Exp. 02/19), and 080916N (Exp. 08/19). The product was distributed nationwide in the U.S.A., as well as in Canada and Australia.

Consumers should stop using the product and contact King Bio Inc. for further instructions.

The recalled product

Product
Dr. King's SafeCare Rx Sleep Aid, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955263920, NDC 57955-2640-2
Manufacturer
King Bio Inc.
Category
Drug — Sleep Aid
Hazard
Affected units
1,244

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: 022318F Exp. 02/20
  • 020416A Exp. 02/19
  • 080916N Exp. 08/19

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 →

Related recalls

Same manufacturer · King Bio Inc.

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Same hazard · microbial contamination

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