Drug recall
Simply Sleep Mini-Caplets, (Diphenhydramine HCl) 25mg, 100 mini-caplets per bottle, McNeil Consumer &…
FDA recall event 34192 · Class II · McNeil Consumer & Specialty Pharmaceuticals, Division of McN
Key facts
| Event ID | 34192 |
|---|---|
| Recall numbers | D-083-6 |
| Recalling firm | McNeil Consumer & Specialty Pharmaceuticals, Division of McN |
| Product type | Drugs |
| Products | Simply Sleep Mini-Caplets, (Diphenhydramine HCl) 25mg, 100 mini-caplets per bottle, McNeil Consumer & Specialty Pharmaceuticals, Division of McNeil-PPC, Inc., Fort Washington, PA ----- NDC… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Presence of foreign substance; product intended for destruction due to foreign object (piece of metal) found while sieving active ingredient 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