Drug recall
Eye Drops advanced relief (Dextran 70 0.1%, Polyethylene glycol 400 1%, Povidone 1%, Tetrahydrozoline HCl…
FDA recall event 55714 · Class II · K C Pharmaceuticals Inc
Key facts
| Event ID | 55714 |
|---|---|
| Recall numbers | D-192-2013 |
| Recalling firm | K C Pharmaceuticals Inc |
| Product type | Drugs |
| Products | Eye Drops advanced relief (Dextran 70 0.1%, Polyethylene glycol 400 1%, Povidone 1%, Tetrahydrozoline HCl 0.05%) ophthalmic solution, 1/2 fl oz (15 mL) bottle, Distributed By Dolgencorp, LLC, 100… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Labeling: Label Mix-Up: Incorrect back labeling of the immediate container of eye drops (unit carton and front label are correct) which do not list three active ingredients: Dextran 70, PEG 400, and… |
| Initiation date | Mar 1, 2010 |
| Report date | Mar 20, 2013 |
| Termination date | Apr 2, 2013 |
| City | Pomona |
| State | CA |
| Country | United States |
| FEI number | 2026940 |
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
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 · Source date: