Why it was recalled
Subpotent; Cetylpyridinum Chloride
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
Lot numbers, UPCs & expiration codes
Lot 611614 (exp. 09/2013)
Where it was sold
Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-418-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 8, 2013
- FDA report date
- May 22, 2013
- Quantity
- 10,440 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hi-Tech Pharmacal Co., Inc.
Original FDA data
Every field from FDA enforcement report D-418-2013, exactly as published.
Show all FDA fields
- City
- Amityville
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 64857
- Address
- 369 Bayview Ave
- Code information
- Lot 611614 (exp. 09/2013)
- Postal code
- 11701-2801
- Report date
- May 22, 2013
- Product type
- Drugs
- Recall number
- D-418-2013
- Classification
- Class III
- Recalling firm
- Hi-Tech Pharmacal Co., Inc.
- Product quantity
- 10,440 bottles
- Termination date
- Apr 30, 2015
- Reason for recall
- Subpotent; Cetylpyridinum Chloride
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Puerto Rico
- Recall initiation date
- Apr 8, 2013
- Initial firm notification
- Letter
- Center classification date
- May 16, 2013