The Recall Desk
ModerateFDA (Drugs)·D-418-2013·Announced 2013-05-22

Hi-Tech Pharmacal Recalls Subpotent Bucalsep Oral Solution

Hi-Tech Pharmacal Co., Inc. is recalling 10,440 bottles of Bucalsep Oral Solution because the cetylpyridinium chloride ingredient is subpotent.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The hazard is a subpotent ingredient, which is a quality issue rather than a direct safety threat like contamination or injury.

Plain-English summary

Hi-Tech Pharmacal Co., Inc. is recalling 10,440 bottles of Bucalsep Oral Solution, 1 Fl. Oz. (30 mL). The product is manufactured for Gil Pharmaceutical Corp. in Ponce, Puerto Rico. The recall is limited to Lot 611614, which has an expiration date of 09/2013.

The recall was initiated because the cetylpyridinium chloride ingredient in the product is subpotent, meaning it does not contain the full amount of the active ingredient stated on the label. The product was distributed in Puerto Rico.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

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
Manufacturer
Hi-Tech Pharmacal Co., Inc.
Category
Drug — Oral Solution
Hazard
Affected units
10,440

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot 611614 (exp. 09/2013)

Distribution

Distributed in 1 state:

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