Nanosil Spray Gel recalled over manufacturing violations

Recall date

April 25, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Conseal International, Inc. recalls Nanosil Spray Gel, "***IMMUNE SYSTEM SUPPORT***ENGINEERED NANO-SILVER SOLUTION***", Net. Wt. 4 fl. oz./118mL, Catalog N…

Recall number

Z-1627-2018

FDA classification

Class II

Brand / firm

Conseal International, Inc.

Sold / distributed

US Distribution to the states of : AL, MS, and MA.

Why it was recalled

A recent FDA inspection of the firm revealed significant Current Good Manufacturing Practices (cGMP) deficiencies including lack of data to support products conform to final specifications, and lack of expiration dates on the product being recalled.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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 microbial infections.