The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-0765-2019·Announced 2019-03-20

King Bio Recalls Dr. King's SafeCare Rx Yeast Freee Due to Microbial Contamination

King Bio Inc. is recalling Dr. King's SafeCare Rx Yeast Freee 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 recall is classified as 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 537 bottles of Dr. King's SafeCare Rx Yeast Freee, 2 fl. oz. (59 mL), due to microbial contamination. The product is identified by NDC 57955-0102-2 and UPC 357955007623.

The affected lots are 081116A (Expiration 08/19) and 022417B (Expiration 02/20). The product was distributed nationwide in the United States, as well as in Canada and Australia.

Consumers should check their inventory for these specific lot numbers and expiration dates. If found, they should stop using the product and follow instructions from the recalling firm or healthcare provider.

The recalled product

Product
Dr. King's SafeCare Rx Yeast Freee..., 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955007623, NDC 57955-0102-2
Manufacturer
King Bio Inc.
Category
Drug — Topical Antifungal
Hazard
Affected units
537

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 (2)

  • Lots: 081116A Exp. 08/19
  • 022417B Exp. 02/20

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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