Drug recall
Diphenhydramine HCL, USP 25mg, softgel capsules 12 counts blister cards, Banner Pharmacaps, Inc., High Point…
FDA recall event 51824 · Class III · Banner Pharmacaps Inc
Key facts
| Event ID | 51824 |
|---|---|
| Recall numbers | D-1220-2009 |
| Recalling firm | Banner Pharmacaps Inc |
| Product type | Drugs |
| Products | Diphenhydramine HCL, USP 25mg, softgel capsules 12 counts blister cards, Banner Pharmacaps, Inc., High Point, NC. |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed USP Dissolution testing at 3-month stability timepoint. |
| Initiation date | Feb 10, 2009 |
| Termination date | Aug 24, 2009 |
| City | High Point |
| State | NC |
| Country | United States |
| FEI number | 3001451366 |
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