Recalls / Class III

Class IIID-418-2013

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

Affected lot / code info

Lot 611614 (exp. 09/2013)

Why it was recalled

Subpotent; Cetylpyridinum Chloride

Recalling firm

Firm

Hi-Tech Pharmacal Co., Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

369 Bayview Ave, Amityville, New York 11701-2801

Distribution

Quantity

10,440 bottles

Distribution pattern

Puerto Rico

Timeline

Recall initiated

2013-04-08

FDA classified

2013-05-16

Posted by FDA

2013-05-22

Terminated

2015-04-30

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-418-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.