King Bio Recalls Dr. King's SafeCare Rx Smoke Control Due to Microbial Contamination
King Bio Inc. is recalling Dr. King's SafeCare Rx Smoke Control bottles 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 the 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 recalling 262 bottles of Dr. King's SafeCare Rx Smoke Control, 2 fl. oz. (59 mL), due to microbial contamination. The affected product is identified by NDC 57955-3031-2 and UPC 357955303022.
The recall covers specific lots: 091015N with an expiration date of 09/18, and 111716H with an expiration date of 11/19. The product was distributed nationwide in the United States, as well as in Canada and Australia.
Consumers should check their inventory for the specific lot numbers and expiration dates listed above. If they possess the affected product, they should stop using it and contact the manufacturer or their healthcare provider for further instructions.
The recalled product
- Product
- Dr. King's SafeCare Rx Smoke Control, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955303022, NDC 57955-3031-2
- Manufacturer
- King Bio Inc.
- Category
- Drug — Topical / Ophthalmic
- Hazard
- Affected units
- 262
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: 091015N Exp. 09/18
- 111716H Exp. 11/19
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.
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