BUCALSEP — Class III drug recall D-418-2013
Terminated recall by Hi-Tech Pharmacal Co., Inc., reported 2013-05-22, distributed in PR. Subpotent; Cetylpyridinum Chloride
| Recall number | D-418-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hi-Tech Pharmacal Co., Inc., Amityville, NY, United States |
| Recall initiated | 2013-04-08 |
| Classified | 2013-05-16 |
| Reported by FDA | 2013-05-22 |
| Terminated | 2015-04-30 |
| Distributed | PR |
| Quantity | 10,440 bottles |
| Reason classes | potency |
| NDC | 58552-0103-01 |
| Lot numbers | 611614 |
| Expiration dates | 2013-09 |
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 for recall
Subpotent; Cetylpyridinum Chloride
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-418-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.