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.
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 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.
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