Drug recall
Extra Strength Super Troche DM, each troche contains 15 mg Benzocaine and 10 mg Dextromethorphan HBr, 10…
FDA recall event 35832 · Class II · Weeks & Leo Co Inc
Key facts
| Event ID | 35832 |
|---|---|
| Recall numbers | D-324-6 |
| Recalling firm | Weeks & Leo Co Inc |
| Product type | Drugs |
| Products | Extra Strength Super Troche DM, each troche contains 15 mg Benzocaine and 10 mg Dextromethorphan HBr, 10 troches per bottle. Distributor: Siro Pharmacy, Schuylkill Haven, PA 17972. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Drug Facts label on back of the bottle does not list Dextromethorphan HBr as an active ingredient and lacks the warning not to use the product if taking a monoamine oxidase inhibitor. |
| Initiation date | Jul 10, 2006 |
| Termination date | Jun 11, 2008 |
| City | Des Moines |
| State | IA |
| Country | United States |
| FEI number | 1910338 |
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