Drug recall
BUCALSEP (R) ORAL SOLUTION, (Benzocaine, 600 mg, Cetylpyridinum Chloride 30 mg, Menthol 45 mg Zinc Chloride 30…
FDA recall event 64857 · Class III · Hi-Tech Pharmacal Co., Inc.
Key facts
| Event ID | 64857 |
|---|---|
| Recall numbers | D-418-2013 |
| Recalling firm | Hi-Tech Pharmacal Co., Inc. |
| Product type | Drugs |
| Products | BUCALSEP (R) ORAL SOLUTION, (Benzocaine, 600 mg, Cetylpyridinum Chloride 30 mg, Menthol 45 mg Zinc Chloride 30 mg), 1 Fl. Oz. (30 mL), Manufactured for GIL PHARMACEUTICAL CORP, PONCE, PUERTO RICO… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Subpotent; Cetylpyridinum Chloride |
| Initiation date | Apr 8, 2013 |
| Report date | May 22, 2013 |
| Termination date | Apr 30, 2015 |
| City | Amityville |
| State | NY |
| Country | United States |
| FEI number | 2433247 |
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 · Source date: