Drug recall
Koff & Kold Spray (huang liam, lugol iodine, quercetin), 1 fl oz bottles, Wholistic Herbs, Inc., 11661 Preston…
FDA recall event 61139 · Class I, Class II · Wholistic Herbs, Inc.
Key facts
| Event ID | 61139 |
|---|---|
| Recall numbers | D-1355-2012, D-1356-2012 |
| Recalling firm | Wholistic Herbs, Inc. |
| Product type | Drugs |
| Products | Koff & Kold Spray (huang liam, lugol iodine, quercetin), 1 fl oz bottles, Wholistic Herbs, Inc., 11661 Preston Rd. #170, Dallas, TX 75230., Kold Sore Spray with liquid sea mineral,1 fl oz bottle, Wholistic Herbs, Inc., 11661 Preston Rd. #170, Dallas, TX 75230. |
| Classification | Class I, Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | CGMP Deviations: This product was manufactured in a manner that lacks good manufacturing practices, Non-Sterility: This product is intended for use in the eye and was manufactured under non sterile conditions |
| Initiation date | Feb 9, 2012 |
| Termination date | Dec 27, 2012 |
| City | Dallas |
| State | TX |
| Country | United States |
| FEI number | 3001239154 |
At a glance
- 1–9 Products in this recall
- 1–9 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
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports