King Bio Recalls Cold Sore Cream Due to Microbial Contamination
King Bio Inc. is recalling Dr. King's SafeCare Rx Cold Sores & Herpes Skin cream 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 FDA has classified this recall as Class I, which per the rubric mandates a severity score of 5 (Critical) due to the potential for serious adverse health consequences.
Plain-English summary
King Bio Inc. is recalling Dr. King's SafeCare Rx Cold Sores & Herpes Skin, 2 fl. oz. (59 mL), due to microbial contamination. The recall involves 783 bottles of the product, identified by NDC 57955-0165-2 and UPC 357955016526.
The affected lots are 032216D (Exp. 03/19), 072815G (Exp. 07/18), and 022017A (Exp. 02/20). The product was distributed nationwide in the United States, as well as in Canada and Australia.
Consumers should stop using the product and check their lot numbers against the list provided. The FDA has classified this as a Class I recall, indicating a reasonable probability that use of the product may cause serious adverse health consequences or death.
The recalled product
- Product
- Dr. King's SafeCare Rx Cold Sores & Herpes Skin, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955016526, NDC 57955-0165-2
- Manufacturer
- King Bio Inc.
- Category
- Drug — Topical Antiviral
- Hazard
- Affected units
- 783
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: 032216D Exp. 03/19
- 072815G Exp. 07/18
- 022017A Exp. 02/20
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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