Drug recall
Infants Tylenol Concentrated Drops Plus Cold, Each 0.8mL contains Acetaminophen 80 mg and Pseudoephedrine HCl…
FDA recall event 34099 · Class III · McNeil Consumer & Specialty Pharmaceuticals, Division of McN
Key facts
| Event ID | 34099 |
|---|---|
| Recall numbers | D-086-6 |
| Recalling firm | McNeil Consumer & Specialty Pharmaceuticals, Division of McN |
| Product type | Drugs |
| Products | Infants Tylenol Concentrated Drops Plus Cold, Each 0.8mL contains Acetaminophen 80 mg and Pseudoephedrine HCl 7.5mg, 1/2 FL OZ (15mL) bottles,McNeil Consumer & Specialty Pharmaceuticals, Division of… |
| Classification | Class III |
| Status | Completed |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed pH specification: product intended for destruction was possibly diverted to the retail market |
| 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