The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-0727-2019·Announced 2019-03-20

King Bio Recalls Asthma Clear Allergy Spray Due to Microbial Contamination

King Bio Inc. is recalling Dr. King's SafeCare Rx Asthma Clear Allergy nasal spray due to microbial contamination. The affected 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 minimum severity score of 4 per the rubric. Microbial contamination in a drug product represents a significant health risk.

Plain-English summary

King Bio Inc. is recalling 797 bottles of Dr. King's SafeCare Rx Asthma Clear Allergy, 2 fl. oz. (59 mL) nasal spray. The recall is being conducted due to microbial contamination. The affected product is identified by NDC 57955-0044-2 and UPC 357955004424.

The recalled product was distributed nationwide in the United States, as well as in Canada and Australia. Specific lots affected include 012116S with an expiration date of 01/19 and 122116A with an expiration date of 12/19.

Consumers who have purchased this product should stop using it and contact King Bio Inc. for further instructions or a refund.

The recalled product

Product
Dr. King's SafeCare Rx Asthma Clear Allergy, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955004424, NDC 57955-0044-2
Manufacturer
King Bio Inc.
Category
Drug — Nasal Spray
Hazard
Affected units
797

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: 012116S Exp. 01/19
  • 122116A Exp. 12/19

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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