# FDA recall D-418-2013

> **Hi-Tech Pharmacal Co., Inc.** · Class III · drug recall initiated 2013-04-08.

## 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

## Distribution

Puerto Rico

## Key facts

- **Recall number:** D-418-2013
- **Recalling firm:** Hi-Tech Pharmacal Co., Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-04-08
- **Report date:** 2013-05-22
- **Termination date:** 2015-04-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Amityville, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-418-2013

## Citation

> AI Analytics. FDA recall D-418-2013. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-418-2013. Source: US FDA. Licensed CC0.

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