Drug recall
Motrin IB (Ibuprofen) Caplets USP, 200mg, Pain Reliever/Fever Reducer (NSAID), 8 count Caplets, Distributed by…
FDA recall event 53140 · Class II · Mcneil Consumer Products Co.
Key facts
| Event ID | 53140 |
|---|---|
| Recall numbers | D-050-2010 |
| Recalling firm | Mcneil Consumer Products Co. |
| Product type | Drugs |
| Products | Motrin IB (Ibuprofen) Caplets USP, 200mg, Pain Reliever/Fever Reducer (NSAID), 8 count Caplets, Distributed by McNeil Consumer Healthcare, DIVISION OF MCNEIL-PPC, INC., Fort Washington, PA |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed S-3 USP Dissolution Specifications; 3 month stability test interval |
| Initiation date | Jun 12, 2009 |
| Termination date | Dec 8, 2011 |
| City | Fort Washington |
| State | PA |
| Country | United States |
| FEI number | 1000656533 |
At a glance
- 1–9 Products in this recall
- None 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