King Bio Recalls Menstrual Cramp Product Due to Microbial Contamination
King Bio Inc. is recalling Dr. King's SafeCare Rx Menstrual Cramps & Irregularities 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 per the rubric.
Plain-English summary
King Bio Inc. is recalling 144 bottles of Dr. King's SafeCare Rx Menstrual Cramps & Irregularities, 2 fl. oz. (59 mL). The recall is due to microbial contamination. The product is identified by NDC 57955-0004-2 and UPC 357955000426.
The affected lots are 083116E (Exp. 08/19) and 052616D (Exp. 05/19). The product was distributed nationwide in the U.S.A., as well as in Canada and Australia.
Consumers should stop using the product and contact King Bio Inc. for a refund or further instructions.
The recalled product
- Product
- Dr. King's SafeCare Rx Menstrual Cramps & Irregularities, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955000426, NDC 57955-0004-2
- Manufacturer
- King Bio Inc.
- Category
- Drug — OTC / Menstrual
- Hazard
- Affected units
- 144
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: 083116E Exp. 08/19
- 052616D Exp. 05/19
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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