D-418-2013 Class III Terminated
FDA drug recall D-418-2013 was initiated by Hi-Tech Pharmacal Co., Inc. on April 8, 2013 and is designated Class III. Reason for recall: Subpotent; Cetylpyridinum Chloride The recall status is terminated (terminated April 30, 2015). Affected quantity: 10,440 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 22, 2013
- Initiation Date
- April 8, 2013
- Termination Date
- April 30, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,440 bottles
Product Description
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 Pattern
Puerto Rico
Code Information
Lot 611614 (exp. 09/2013)