Status
Terminated
Drug Enforcement D-418-2013
Subpotent; Cetylpyridinum Chloride
Classification
Class III
Report Date
May 22, 2013
Termination Date
April 30, 2015
Product Information
- 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
- Product quantity
- 10,440 bottles
- Reason for recall
- Subpotent; Cetylpyridinum Chloride
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Puerto Rico
Location & Firm
- Recalling firm
- Hi-Tech Pharmacal Co., Inc.
- Address
-
369 Bayview Ave
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-418-2013
- Event ID
- 64857
- Recall initiation date
- April 8, 2013
- Center classification date
- May 16, 2013
- Code info
- Lot 611614 (exp. 09/2013)
- More code info
- —