King Bio Recalls Sore Throat Spray Due to Microbial Contamination
King Bio Inc. is recalling Dr. King's SafeCare Rx Sore Throat & Laryngitis 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 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 agency classification is FDA Class I, which is defined as a situation where use of or exposure to a violative product may cause serious adverse health consequences or death.
Plain-English summary
King Bio Inc. is recalling 340 bottles of Dr. King's SafeCare Rx Sore Throat & Laryngitis, 2 fl. oz. (59 mL). The recall is due to microbial contamination. The product is identified by NDC 57955-0137-2 and UPC 357955005827.
The affected lots are 072815M (Exp. 07/18), 031016K (Exp. 03/19), and 030718H (Exp. 03/20). The product was distributed nationwide in the U.S.A., as well as in Canada and Australia.
Consumers should check their inventory for these specific lot numbers and expiration dates. If the product matches the recalled description, it should be returned to the point of purchase or disposed of according to local regulations.
The recalled product
- Product
- Dr. King's SafeCare Rx Sore Throat & Laryngitis, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955005827, NDC 57955-0137-2
- Manufacturer
- King Bio Inc.
- Category
- Drug — Topical / OTC
- Hazard
- Affected units
- 340
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: 072815M Exp. 07/18
- 031016K Exp. 03/19
- 030718H 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.
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