Drug recall
Children''s Tylenol Flu Suspension 4 oz bottle. Acetaminophen (APAP) 160 mg, chlorpheniramine maleate (CPM) 1…
FDA recall event 34253 · Class II · McNeil Consumer & Specialty Pharmaceuticals, Division of McN
Key facts
| Event ID | 34253 |
|---|---|
| Recall numbers | D-094-6 |
| Recalling firm | McNeil Consumer & Specialty Pharmaceuticals, Division of McN |
| Product type | Drugs |
| Products | Children''s Tylenol Flu Suspension 4 oz bottle. Acetaminophen (APAP) 160 mg, chlorpheniramine maleate (CPM) 1 mg, dextromethorphan HBr (DXM) 7.5 mg, pseudoephedrine HCl (PSE) 15 mg per 5 ml… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Presence of particulate matter: Product intended for destruction due to a small piece of black foreign material observed on the packaging screen was possibly diverted to retail stores |
| Initiation date | Sep 19, 2005 |
| City | Fort Washington |
| 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