Drug recall
Zyrtec Itchy Eye Drops (ketotifen fumarate) ophthalmic solution, 0.025%, 0.17 FL OZ (5 mL) bottle, Distributed…
FDA recall event 55291 · Class II · McNeil Consumer Healthcare, Div of McNeil-PPC, Inc.
Key facts
| Event ID | 55291 |
|---|---|
| Recall numbers | D-542-2010 |
| Recalling firm | McNeil Consumer Healthcare, Div of McNeil-PPC, Inc. |
| Product type | Drugs |
| Products | Zyrtec Itchy Eye Drops (ketotifen fumarate) ophthalmic solution, 0.025%, 0.17 FL OZ (5 mL) bottle, Distributed by: McNeil Consumer Healthcare, DIVISION OF MCNEIL-PPC, INC., FORT WASHINGTON, PA 19034… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed PH Specifications: out of specification (OOS) results for pH during stability testing |
| Initiation date | Mar 29, 2010 |
| Termination date | Oct 27, 2012 |
| City | Fort Washington |
| State | PA |
| Country | United States |
| FEI number | 2510184 |
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