The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-0715-2019·Announced 2019-03-20

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

King Bio Inc. is recalling 549 bottles of Dr. King's SafeCare Rx ICV Clenz Cleansing & Detox 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 FDA has classified this recall as Class I, which meets the rubric criteria for a Critical severity score (5).

Plain-English summary

King Bio Inc. is recalling 549 bottles of Dr. King's SafeCare Rx ICV Clenz Cleansing & Detox, 2 fl. oz. (59 mL), due to microbial contamination. The product is identified by NDC 57955-0262-2 and UPC 357955009825. The affected lots are 081015G (Exp. 08/18), 030916B (Exp. 03/19), 012317B (Exp. 01/20), and 010818A (Exp. 01/20).

The recall covers distribution across the United States, Canada, and Australia. The FDA has classified this recall as Class I, which is the most serious classification for drug recalls.

Consumers should stop using the product and contact King Bio Inc. for further instructions or a refund. The source text does not specify a particular consumer action beyond the standard recall protocol, nor does it report any specific illnesses or injuries associated with the contamination.

The recalled product

Product
Dr. King's SafeCare Rx ICV Clenz Cleansing & Detox, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955009825, NDC 57955-0262-2
Manufacturer
King Bio Inc.
Category
Drug — Supplement
Hazard
Affected units
549

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 (4)

  • Lots: 081015G Exp. 08/18
  • 030916B Exp. 03/19
  • 012317B Exp. 01/20
  • 010818A Exp. 01/20

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 →

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