Home › PREMIER DENTAL PRODUCTS COMPANY › Gynex Lugols
Gynex Lugols
PREMIER DENTAL PRODUCTS COMPANY · Model 9045066 · UDI-DI 00348783015577
IAM
Prescription
0
510(k) clearances
0
Adverse events
1
Recalls
16
Facilities
Description
Lugol's Strong Iodine Solution, Non-Sterile, Single-Patient-Use, 12 single application - 8mL vials, 12 rayon tipped applicators
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-10-17 | EMD Millipore Corporation | Due to the incorrect packaging utilized with lot 3124, there' s an improper seal between the cap and bottle. With an improper seal the Assay (current specification of 24.8 to 27.2 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.