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Recall Observatory FDA recall evidence

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.

Z-1627-2018

April 25, 2018

Class II

Product summary

Firm
Conseal International, Inc.
Event
Event 79962
Status
Terminated
Classification
Class II
Quantity
384
Official record key
device-enforcement:Z-1627-2018

Official wording

Reason: 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.

Code information: Product does not bear lot codes. All product lacking lot codes and expiration dates is being recalled.

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

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    Current Good Manufacturing Practices (cGMP) deficiencies