Symbio Muc Eye Recalled Due to Lack of Sterility Assurance
Deserving Health International Corp is recalling Symbio Muc Eye eye drops because the product lacks assurance of sterility. The affected units were distributed throughout the United States.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 II. According to the rubric, an FDA Class II recall involving a sterile product defect (lack of assurance of sterility) is categorized as Severe (Score 4), as it poses a significant risk of infection or injury.
Plain-English summary
Deserving Health International Corp is voluntarily recalling 623 dropper bottles of Symbio Muc Eye, 0.17 fl.oz. 5mL bottles. The recall is being conducted because the product lacks assurance of sterility. The product was manufactured for and distributed in the US by Biological Health Group Corp. in Bremerton, WA.
The affected product is identified by NDC 69711-125-61. Specific lots involved in the recall include DM17B12 (Expiration 03/2020), DM16L44 (Expiration 12/2019), and DM16L07 (Expiration 12/2019). The product was distributed throughout the United States.
Consumers should stop using the product and return it to the point of purchase or contact the recalling firm for instructions on disposal or refund.
The recalled product
- Product
- Symbio Muc Eye, 0.17 fl.oz. 5mL bottles, Manufactured for and distributed in the US b: Biological Health Group Corp. Bremerton, WA 98337. NDC 69711-125-61
- Manufacturer
- Deserving Health International Corp
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 623
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 (6)
- Lot #: DM17B12
- Exp 03/2020
- DM16L44
- Exp 12/2019
- DM16L07
- Exp12/2019
Distribution
Distribution scope not specified by the agency.
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