King Bio Recalls Safecare+ Allergy Spray Due to Microbial Contamination
King Bio Inc. is recalling 895 bottles of Safecare+ Southeast Regional Allergies Homeopathic Oral Spray 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 according to the rubric.
Plain-English summary
King Bio Inc. is recalling 895 bottles of Safecare+ Southeast Regional Allergies Homeopathic Non-Drowsy Taste Free, Oral Spray, 1 fl oz (29.6 mL). The recall is due to microbial contamination. The affected product has the UPC 357955834519 and NDC 57955-8345-1.
The recalled lots are 013017K (Expiration 01/20) and 080515A (Expiration 08/18). 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 a refund or further instructions.
The recalled product
- Product
- Safecare+ Southeast Regional Allergies Homeopathic Non-Drowsy Taste Free, Oral Spray, 1 fl oz (29.6 mL), UPC 357955834519, NDC 57955-8345-1
- Manufacturer
- King Bio Inc.
- Category
- Drug — Homeopathic
- Hazard
- Affected units
- 895
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: 013017K Exp. 01/20
- 080515A Exp. 08/18
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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