FDA recall D-418-2013

Hi-Tech Pharmacal Co., Inc. · Class III · drug

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

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

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