The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-0702-2019·Announced 2019-03-20

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

King Bio Inc. is recalling Dr. King's SafeCare Rx Allergies Southern U.S. Allergy nasal spray due to microbial contamination. The recall covers 2,027 bottles 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 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The recall is classified as FDA Class I, which meets the rubric criteria for a Critical severity score (5) due to the potential for serious adverse health consequences.

Plain-English summary

King Bio Inc. is recalling 2,027 bottles of Dr. King's SafeCare Rx Allergies Southern U.S. Allergy, 2 fl. oz. (59 mL), due to microbial contamination. The product is identified by NDC 57955-2721-2 and UPC 357955260127.

The affected lots are 050216AA (Exp. 05/19), 101116B (Exp. 10/19), and 010118K (Exp. 01/20). 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. This recall is classified as FDA Class I, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.

The recalled product

Product
Dr. King's SafeCare Rx Allergies Southern U.S. Allergy, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955260127, NDC 57955-2721-2
Manufacturer
King Bio Inc.
Category
Drug — Nasal Spray
Hazard
Affected units
2,027

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 (3)

  • Lots: 050216AA Exp. 05/19
  • 101116B Exp. 10/19
  • 010118K Exp. 01/20

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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