FDA Drug recall D-418-2013
BUCALSEP (R) ORAL SOLUTION, (Benzocaine, 600 mg, Cetylpyridinum Chloride 30 mg, Menthol 45 mg Zinc Chloride 30 mg), 1 Fl. Oz. (30 mL), Manu…
- FDA Drug
- Class III
- terminated
- Published 2013-05-22
On 2013-05-22 the FDA classified a Class III recall of BUCALSEP (R) ORAL SOLUTION, (Benzocaine, 600 mg, Cetylpyridinum Chloride 30 mg, Menthol 45 mg Zinc Chloride 30 mg), 1 Fl. Oz. (30 mL), Manu… by Hi Tech Pharmacal, citing subpotent; Cetylpyridinum Chloride.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-418-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-04-08 |
| Published | 2013-05-22 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Hi Tech Pharmacal |
| Distribution | PR |
Product
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 00717-1565 -- NDC 58552-103-01
Reason
Subpotent; Cetylpyridinum Chloride
Identifiers
| code_info | Lot 611614 (exp. 09/2013) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-418-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.