Drug recall
Benadryl-D Allergy & Sinus Antihistamine, Nasal Decongestant Tablets (Diphenhydramine HCl 25 mg and…
FDA recall event 44877 · Class II, Class III · McNeil Consumer Healthcare, Div of McNeil-PPC, Inc.
Key facts
| Event ID | 44877 |
|---|---|
| Recall numbers | D-006-2008, D-007-2008 |
| Recalling firm | McNeil Consumer Healthcare, Div of McNeil-PPC, Inc. |
| Product type | Drugs |
| Products | Benadryl-D Allergy & Sinus Antihistamine, Nasal Decongestant Tablets (Diphenhydramine HCl 25 mg and Phenylephrine HCl 10 mg), 24-tablet cartons or trays and 3-24 tablet club cartons. Dist: Pfizer…, SUDAFED PE Nighttime Nasal Decongestant Tablets (Diphenhydramine HCl 25 mg and Phenylephrine HCl 10 mg), 12-tablet carton, NDC 0501-2914-12. Dist: Pfizer Consumer Healthcare, Morris Plains, NJ 07950… |
| Classification | Class II, Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Product failed specification for dosage uniformity and may contain some tablets with higher dose than label amount., Product failed specification for dosage uniformity and may contain some tablets with lower dose than label amount. |
| Initiation date | Aug 20, 2007 |
| Termination date | Jun 21, 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