CLASS III Drug recall · Reported 22 May 2013 · FDA Enforcement Report
Bucalsep (R) Oral Solution, (Benzocaine, 600 mg recalled
Hi-Tech Pharmacal is recalling Bucalsep (R) Oral Solution, (Benzocaine, 600 mg, Cetylpyridinum Chloride 30 mg, Menthol, distributed in Puerto Rico. The recall was initiated on 8 Apr 2013 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-418-2013
- FDA event ID
- 64857
- Recalling firm
- Hi-Tech Pharmacal, Amityville, NY
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 8 Apr 2013
- FDA classified
- 16 May 2013
- Reported
- 22 May 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 8 Apr 2013 | Recall initiated by company | |
| 16 May 2013 | Classified by FDA | +38 days |
| 22 May 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent; Cetylpyridinum Chloride
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Puerto Rico
Questions about this recall
Why was it recalled?
Subpotent; Cetylpyridinum Chloride
Which lots are affected?
Lot 611614 (exp. 09/2013)
Where was it sold?
Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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