King Bio Recalls Dr. King's SafeCare Rx Spaced Out Due to Microbial Contamination
King Bio Inc. is recalling Dr. King's SafeCare Rx Spaced Out 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 agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
King Bio Inc. is recalling 32 bottles of Dr. King's SafeCare Rx Spaced Out, 2 fl. oz. (59 mL), due to microbial contamination. The product is identified by NDC 57955-1541-2 and UPC 357955154020.
The recall affects specific lots: 052516E (Exp. 05/19) and 121317E (Exp. 12/19). The product was distributed nationwide in the United States, as well as in Canada and Australia.
Consumers should check their inventory for these specific lot numbers and expiration dates. If found, they should stop using the product and contact the manufacturer for instructions on disposal or return.
The recalled product
- Product
- Dr. King's SafeCare Rx Spaced Out, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955154020, NDC 57955-1541-2
- Manufacturer
- King Bio Inc.
- Category
- Drug — Topical Antifungal
- Hazard
- Affected units
- 32
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: 052516E Exp. 05/19
- 121317E 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.
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