🔍 RecallPedia

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

Class I - Dangerous
💊 Drugs Recalled: April 8, 2013 Hi-Tech Pharmacal Co. Prescription Drugs

What Should You Do?

  1. Check if you have this product:
    Lot 611614 (exp. 09/2013)
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Hi-Tech Pharmacal Co., Inc.
Reason for Recall:
Subpotent; Cetylpyridinum Chloride
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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

Product Codes/Lot Numbers:

Lot 611614 (exp. 09/2013)

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-418-2013

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