Drug recall
activator concentrate, Sodium Fluoride 0.96% in Activator Concentrate; 0.08% in diluted Activator Solution…
FDA recall event 92857 · Class II · Ecometics, Inc.
Key facts
| Event ID | 92857 |
|---|---|
| Recall numbers | D-1096-2023, D-1097-2023, D-1098-2023, D-1099-2023, D-1100-2023, D-1101-2023, D-1102-2023 |
| Recalling firm | Ecometics, Inc. |
| Product type | Drugs |
| Products | activator concentrate, Sodium Fluoride 0.96% in Activator Concentrate; 0.08% in diluted Activator Solution, Net 1 FL. OZ., Manufactured for: All USA Direct, LLC, Broadview, IL 60155., ALCOLADO RELAMPAGO (Menthol and Camphor), 1% and 1.5% respectively, packaged in a 7 FLUID OZ (207 ml) bottles, UPC 7 18864 20102 9 and b) 16 FLUID OZ (472 ml) bottles, UPC 7 18864, 20110 4…, AstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm Single Use Vials, Manufactured for CooperSurgical, Trumbull, CT 06611, NDC 59365-6065-0, Ref 6065., Blis-To-Sol Liquid (Tolnaftate), 1%, packaged in a) 1 FLUID OZ. (29.5 mL) bottles, UPC 0 11169 20011 8 and b) 1.85 FLUID OZ. (54.5 mL) bottles, UPC 0 11169 20012 5, Distributed by Oakhurst Company…, Lugol's (Strong Iodine Solution USP), Each mL contains Iodine 0.05gm and potassium iodide 0.100gm, 8mL Single Use Vials, Rx Only, Manufactured for CooperSurgical, Trumbull, CT 06611, NDC 59365-6064-0… and 2 more |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | CGMP Deviations: Products not manufactured under current good manufacturing practices. |
| Initiation date | Aug 9, 2023 |
| Report date | Aug 30, 2023 |
| City | Norwalk |
| State | CT |
| Country | United States |
| FEI number | 1250013 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
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Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: