FDA Device recall Z-1627-2018
Nanosil Spray Gel, "***IMMUNE SYSTEM SUPPORT***ENGINEERED NANO-SILVER SOLUTION***", Net
- FDA Device
- Class II
- terminated
- Published 2018-05-09
On 2018-05-09 the FDA classified a Class II recall of Nanosil Spray Gel, "***IMMUNE SYSTEM SUPPORT***ENGINEERED NANO-SILVER SOLUTION***", Net by Conseal International, citing 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 speci….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1627-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-04-25 |
| Published | 2018-05-09 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Conseal International |
| Distribution | AL, MA, MS |
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
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.
Identifiers
| code_info | Product does not bear lot codes. All product lacking lot codes and expiration dates is being recalled. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1627-2018%22
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