The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-0768-2019·Announced 2019-03-20

King Bio Recalls ParaClenz Due to Microbial Contamination

King Bio Inc. is recalling Dr. King's SafeCare Rx ParaClenz 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this as a Class I recall, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. Per the rubric, FDA Class I recalls are assigned a score of 4 or higher.

Plain-English summary

King Bio Inc. is recalling 795 bottles of Dr. King's SafeCare Rx ParaClenz, 2 fl. oz. (59 mL), due to microbial contamination. The product is identified by NDC 57955-0193-2 and UPC 357955001621.

The recall covers specific lots with expiration dates ranging from August 2018 to March 2020. The affected product was distributed nationwide in the United States, as well as in Canada and Australia.

Consumers should stop using the product and return it to the point of purchase for a refund or contact the manufacturer for instructions.

The recalled product

Product
Dr. King's SafeCare Rx ParaClenz, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955001621, NDC 57955-0193-2
Manufacturer
King Bio Inc.
Category
Drug — Parasitic Treatment
Hazard
Affected units
795

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: 081015J Exp. 08/18
  • 062816A Exp. 06/19
  • 101716B Exp. 10/19
  • 030718A Exp. 03/20

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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