Drug recall
Orasept Antiseptic Mouthwash & Gargle (cetylpyridinium HCl 0.05% w/w), 4 fl. oz. (118 mls.) bottles…
FDA recall event 28898 · Class II · Pharmakon Laboratory, Inc.
Key facts
| Event ID | 28898 |
|---|---|
| Recall numbers | D-182-4 |
| Recalling firm | Pharmakon Laboratory, Inc. |
| Product type | Drugs |
| Products | Orasept Antiseptic Mouthwash & Gargle (cetylpyridinium HCl 0.05% w/w), 4 fl. oz. (118 mls.) bottles, over-the-counter, Formulated & Manufactured by Pharmakon Labs, Inc., Tampa, FL 33634 ---- NDC… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Microbial contamination (yeast and mold) |
| Initiation date | Apr 19, 2004 |
| Termination date | Jul 8, 2012 |
| City | Tampa |
| State | FL |
| Country | United States |
| FEI number | 1051110 |
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