The Recall Desk
CriticalFDA (Drugs)·D-0678-2019·Announced 2019-03-20

King Bio Recalls Homeopathic Digestion Formula Due to Microbial Contamination

King Bio Inc. is recalling Dr. King's SafeCare Rx Lower GI Restoration Digestion Formula 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 indicates a reasonable probability that use of the product will cause serious adverse health consequences or death.

Plain-English summary

King Bio Inc. is recalling 659 bottles of Dr. King's SafeCare Rx Lower GI Restoration Digestion High Potency Homeopathic Formula for Professional Use Only. The recall is being conducted because the product is subject to microbial contamination.

The affected product is a 2 fl. oz. (59 mL) liquid formula manufactured by King Bio Inc. in Asheville, North Carolina. It is identified by NDC 57955-0322-2 and UPC 357955032021. The recall covers specific lots with expiration dates in March 2019, July 2019, and December 2019.

The product was distributed nationwide in the United States, as well as in Canada and Australia. Consumers and healthcare professionals should stop using the product and contact King Bio Inc. for further instructions or a refund.

The recalled product

Product
Dr. King's SafeCare Rx Lower GI Restoration Digestion High Potency Homeopathic Formula for Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside dr. Asheville, NC 28806 USA, UPC 357955032021, NDC 57955-0322-2
Manufacturer
King Bio Inc.
Category
Drug — Homeopathic
Hazard
Affected units
659

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: 030916J Exp. 03/19
  • 072516D Exp. 07/19
  • 121717A Exp. 12/19

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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