King Bio Recalls Children's Cough Syrup Due to Microbial Contamination
King Bio Inc. is recalling Dr. King's SafeCare Rx Children's Cough 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 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 criteria for a Critical severity score.
Plain-English summary
King Bio Inc. is recalling 165 bottles of Dr. King's SafeCare Rx Children's Cough Children High Potency Homeopathic Formula for Professional Use Only. The recall was initiated because the product is subject to microbial contamination.
The affected product is a 2 fl. oz. (59 mL) bottle with UPC 357955014522 and NDC 57955-0145-2. The recall includes lots 091015B (Exp. 09/2018) and 120616B (Exp. 12/2019). 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. The recall is classified as Class I by the FDA.
The recalled product
- Product
- Dr. King's SafeCare Rx Children's Cough Children High Potency Homeopathic Formula for Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955014522, NDC 57955-0145-2
- Manufacturer
- King Bio Inc.
- Category
- Drug — Homeopathic
- Hazard
- Affected units
- 165
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: 091015B Exp. 09/2018
- 120616B Exp. 12/2019
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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