FDA recall Z-1627-2018

Conseal International, Inc. · Class II · device

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 microbial infections.

Reason for recall

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.

Distribution

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

Key facts

Status
Terminated
Initiation date
2018-04-25
Report date
2018-05-09
Termination date
2019-04-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Norwood, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1627-2018