King Bio Recalls Breast Cyst Discomfort Remedy Due to Microbial Contamination
King Bio Inc. is recalling Dr. King's SafeCare Rx Breast Cyst & Discomforts because the product may be contaminated with microorganisms.
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 FDA classified this recall as Class I. According to the rubric, FDA Class I recalls are assigned a severity score of at least 4.
Plain-English summary
King Bio Inc. has initiated a recall of Dr. King's SafeCare Rx Breast Cyst & Discomforts, 2 fl. oz. (59 mL). The company is recalling 98 bottles due to potential microbial contamination.
The recalled product was distributed nationwide in the U.S.A., as well as in Canada and Australia. Affected units have lot numbers 091515A with an expiration date of 09/18, and 010517B with an expiration date of 01/20.
Consumers who possess this product should stop using it immediately.
The recalled product
- Product
- Dr. King's SafeCare Rx Breast Cyst & Discomforts, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955000327, NDC 57955-0003-2
- Manufacturer
- King Bio Inc.
- Category
- Drug — Homeopathic Remedy
- Hazard
- Affected units
- 98
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: 091515A Exp. 09/18
- 010517B Exp. 01/20
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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