April 2013 FDA Recall Drug by Hi-tech Pharmacal Co., Inc.
D-418-2013 - Subpotent; Cetylpyridinum Chloride

This Class III drug recall was voluntarily initiated by Hi-tech Pharmacal Co., Inc. on April 8, 2013 for the product Drug. The FDA reported the reason for recall as subpotent; cetylpyridinum chloride. The product was distributed in Puerto Rico and the recall is currently terminated.

Recall Number: D-418-2013

Reason for Recall
Subpotent; Cetylpyridinum Chloride
Initiated
04-08-2013
Reported
05-22-2013
Quantity
10,440 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64857
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Hi-Tech Pharmacal Co., Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-30-2015
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Lot 611614 (exp. 09/2013)