The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-0769-2019·Announced 2019-03-20

FDA Recalls Dr. King's SafeCare Rx Nosebleed Relief Due to Microbial Contamination

King Bio Inc. is recalling Dr. King's SafeCare Rx Nosebleed Relief 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 or exposure to the violative product will cause serious adverse health consequences or death. Per the rubric, FDA Class I recalls are assigned a severity score of 4 or higher.

Plain-English summary

King Bio Inc. is voluntarily recalling 35 bottles of Dr. King's SafeCare Rx Nosebleed Relief, 2 fl. oz. (59 mL). The recall is being conducted because the product is subject to microbial contamination. The affected product is identified by NDC 57955-0140-2 and UPC 357955014027.

The recall covers two specific lots: 051716K with an expiration date of 05/19, and 030317A with an expiration date of 03/20. The product was distributed nationwide in the United States, as well as in Canada and Australia.

Consumers who have purchased this product should check their lot numbers and expiration dates against the information provided. If the product matches the recalled lots, consumers should stop using it and contact the manufacturer or their healthcare provider for further instructions.

The recalled product

Product
Dr. King's SafeCare Rx Nosebleed Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955014027, NDC 57955-0140-2
Manufacturer
King Bio Inc.
Category
Drug — Topical Ophthalmic/ENT
Hazard
Affected units
35

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: 051716K Exp. 05/19
  • 030317A 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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