Drug product
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
D-418-2013
Product summary
- Event
- Event 64857
- Status
- Terminated
- Classification
- Class III
- Quantity
- 10,440 bottles
- Official record key
drug-enforcement:D-418-2013
Official wording
Reason: Subpotent; Cetylpyridinum Chloride
Code information: Lot 611614 (exp. 09/2013)
Distribution pattern: Puerto Rico
Derived failure modes
-
Potency or specification failure
Subpotent