non-compliance was found consisting in exceeding the lower limit of benzocaine content, exceeding the permissible limit of benzocaine-related substances (single unknown impurity and total impurities), and crumbling of tablets after abrasion resistance testing. Potential effects: lack of treatment efficacy, unknown risk from impurities, possible adverse effects.
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Important Information
Do not use the product from any batch. Check the product name and GTIN numbers on the packaging. Return any packs in your possession to a pharmacy or consult a doctor or pharmacist.
Withdrawal of all batches of the product from the market throughout the country, prohibition of placing all batches on the market, and granting the decision immediate enforceability.
If you feel unwell after consuming this product, contact your doctor or call the poison control center.
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