The Recall Desk
CriticalFDA (Drugs)·D-0841-2019·Announced 2019-03-20

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

King Bio Inc. is recalling 225 bottles of Dr. King's SafeCare Rx Hydration 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 225 bottles of Dr. King's SafeCare Rx Hydration, 2 fl. oz. (59 mL), due to microbial contamination. The product is identified by NDC 57955-0100-2 and UPC 357955010029.

The affected lots are 062615B (Exp. 06/18), 121916D (Exp. 12/19), and 092617E (Exp. 09/19). The product was distributed nationwide in the United States, as well as in Canada and Australia.

Consumers should check their inventory for these specific lot numbers and expiration dates. If found, they should stop using the product and contact the recalling firm for further instructions.

The recalled product

Product
Dr. King's SafeCare Rx Hydration, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955010029, NDC 57955-0100-2
Manufacturer
King Bio Inc.
Category
Drug — Hydration Solution
Hazard
Affected units
225

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: 062615B Exp. 06/18
  • 121916D Exp. 12/19
  • 092617E 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 →

Related recalls

Same manufacturer · King Bio Inc.

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Same hazard · microbial contamination

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