Nanosil Spray Gel Recalled for Manufacturing Deficiencies and Missing Expiration Dates
Conseal International is recalling 384 units of Nanosil Spray Gel due to FDA inspection findings of manufacturing deficiencies and missing expiration dates.
The agency’s classification
FDA (Devices): 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text cites manufacturing deficiencies and missing expiration dates but does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Conseal International, Inc. is recalling 384 units of Nanosil Spray Gel, Catalog No. NSP-04. The product is a topical spray marketed for immune system support and the treatment of discomfort caused by microbial infections. The recall is limited to units distributed in the states of Alabama, Mississippi, and Massachusetts.
The recall was initiated following a recent FDA inspection that identified significant Current Good Manufacturing Practices (cGMP) deficiencies. These deficiencies include a lack of data to support that the products conform to final specifications and the absence of expiration dates on the recalled product. The product does not bear lot codes, and all product lacking lot codes and expiration dates is being recalled.
Consumers who have purchased this product should stop using it and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Nanosil Spray Gel, "***IMMUNE SYSTEM SUPPORT***ENGINEERED NANO-SILVER SOLUTION***", Net. Wt. 4 fl. oz./118mL, Catalog No. NSP-04 The product is a topical spray used to treat discomfort and other pathological conditions affecting exposed soft tissues of the body caused by…
- Manufacturer
- Conseal International, Inc.
- Category
- Medical Device — Topical Spray
- Affected units
- 384
Distribution
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