Reported May 22, 2013 · Terminated
BUCALSEP (R) ORAL SOLUTION, (Benzocaine, 600 mg, Cetylpyridinum Chloride 30 mg, Menthol 45 mg Zinc Chloride 30 mg), 1…
Hi-Tech Pharmacal Co., Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hi-Tech Pharmacal Co., Inc. · 369 Bayview Ave · Amityville, NY · 11701-2801
Is this the product you have?
- 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 codes and dates
- Lot 611614 (exp. 09/2013)
- Amount recalled
- 10,440 bottles
Where it was sold
Why it was recalled
Subpotent; Cetylpyridinum Chloride
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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