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Terminated

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.

FDA Recall Z-1627-2018 · Posted None

Recalling FirmConseal International, Inc.
Recall StatusTerminated
Product CodeFRO
Date Initiated2018-04-25
Date Terminated2019-04-02
Product Quantity384

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.

Firm Action

ConSeal sent an Urgent Medical Device Recall letter dated April 25, 2018, to its customers via email. The letter instructed customers to locate the affected product, quarantine, and return it to the firm. Customers were also instructed to complete and return the customer response form, and inform any users the customer distributed the product to. Customers may contact the firm by calling 782-352-0490. For further questions, please call (781) 278-0010.

Root Cause

Employee error

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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