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
Reported: May 22, 2013 Initiated: April 8, 2013 #D-418-2013
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
Details
- Recalling Firm
- Hi-Tech Pharmacal Co., Inc.
- Units Affected
- 10,440 bottles
- Distribution
- Puerto Rico
- Location
- Amityville, NY
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Hi-Tech Pharmacal Co., Inc.. Units affected: 10,440 bottles.
Why was this product recalled? ▼
Subpotent; Cetylpyridinum Chloride
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 22, 2013. Severity: Low. Recall number: D-418-2013.
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