The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-0739-2019·Announced 2019-03-20

King Bio Recalls LymePlex Due to Microbial Contamination

King Bio Inc. is recalling Dr. King's SafeCare Rx LymePlex 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 classification is FDA Class I, which mandates a severity score of at least 4 per the rubric.

Plain-English summary

King Bio Inc. is voluntarily recalling 95 bottles of Dr. King's SafeCare Rx LymePlex, 2 fl. oz. (59 mL), due to microbial contamination. The product is identified by NDC 57955-0069-2 and UPC 357955006923.

The affected lots are 072815F (Exp. 07/18), 061716C (Exp. 06/19), 020817D (Exp. 02/20), and 030518F (Exp. 03/20). The product was distributed nationwide in the U.S.A., as well as in Canada and Australia.

Consumers 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 LymePlex, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955006923, NDC 57955-0069-2
Manufacturer
King Bio Inc.
Category
Drug — Biological / Supplement
Hazard
Affected units
95

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: 072815F Exp. 07/18
  • 061716C Exp. 06/19
  • 020817D Exp. 02/20
  • 030518F 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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