FDA Recalls Dr. King's SafeCare Rx Diarrhea Relief Due to Microbial Contamination
King Bio Inc. is recalling 205 bottles of Dr. King's SafeCare Rx Diarrhea Relief 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 score of 4 or higher.
Plain-English summary
King Bio Inc. is recalling 205 bottles of Dr. King's SafeCare Rx Diarrhea Relief, 2 fl. oz. (59 mL), due to microbial contamination. The product is identified by UPC 357955002024 and NDC 57955-0020-2.
The affected lots are 072815N (Expiration 07/18) and 081816A (Expiration 08/19). The product was distributed nationwide in the U.S.A., as well as in Canada and Australia.
Consumers should stop using the product and return it to the place of purchase for a refund or contact King Bio Inc. for further instructions.
The recalled product
- Product
- Dr. King's SafeCare Rx Diarrhea Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955002024, NDC 57955-0020-2
- Manufacturer
- King Bio Inc.
- Category
- Drug — OTC Diarrhea Relief
- Hazard
- Affected units
- 205
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: 072815N Exp. 07/18
- 081816A Exp. 08/19
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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