Drug recall
delos (benzoyl peroxide) cleanser, 3.5%, 6 oz (180 g) tube, Rx only, Distributed by: Rochester…
FDA recall event 60243 · Class III · IGI Inc.
Key facts
| Event ID | 60243 |
|---|---|
| Recall numbers | D-838-2012 |
| Recalling firm | IGI Inc. |
| Product type | Drugs |
| Products | delos (benzoyl peroxide) cleanser, 3.5%, 6 oz (180 g) tube, Rx only, Distributed by: Rochester Pharmaceuticals, Rochester, NY 14625, www.RochesterPharm.com, NDC 49908-123-80 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Subpotent (Single Ingredient) Drug: Low assay results for benzoyl peroxide was found during stability testing. |
| Initiation date | Jul 18, 2011 |
| Termination date | Feb 18, 2015 |
| City | Buena |
| State | NJ |
| Country | United States |
| FEI number | 1000526875 |
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