FDAFDA · Food and drugs·Recall number D-418-2013
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
Published May 22, 2013 · Recall initiated: April 8, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Subpotent; Cetylpyridinum Chloride
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Hi-Tech Pharmacal Co., Inc.
- Distributor
- Puerto Rico
- Lot
- Lot 611614 (exp. 09/2013)
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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