King Bio Recalls Poison Ivy Relief Cream Due to Microbial Contamination
King Bio Inc. is recalling Dr. King's SafeCare Rx Poison Ivy & Oak Relief cream because of 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 meets the rubric criteria for a Critical severity score.
Plain-English summary
King Bio Inc. is recalling 441 bottles of Dr. King's SafeCare Rx Poison Ivy & Oak Relief, 2 fl. oz. (59 mL), due to microbial contamination. The product is identified by NDC 57955-0116-2 and UPC 357955011620.
The recalled lots are 091015L (expiration date 09/18) and 092216F (expiration date 09/19). The product was distributed nationwide in the United States, as well as in Canada and Australia.
Consumers should stop using the product and contact King Bio Inc. for further instructions or a refund. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.
The recalled product
- Product
- Dr. King's SafeCare Rx Poison Ivy & Oak Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955011620, NDC 57955-0116-2
- Manufacturer
- King Bio Inc.
- Category
- Drug — Topical OTC
- Hazard
- Affected units
- 441
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: 091015L Exp. 09/18
- 092216F Exp. 09/19
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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