The application explained that the manufacturer is preparing documentation on the root cause of the non-conformity, implemented corrective and preventive actions, and identified violations of the product’s quality requirements. Potential effects: possible reduced treatment effectiveness or occurrence of unexpected adverse reactions.
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Important Information
Do not use the batches subject to suspension. Check the batch number on the packaging; if you have these batches, consult a pharmacist or doctor and consider returning the product to the pharmacy.
The nationwide marketing of the specified batches of Reparil Gel N was suspended, the decision was partially revoked for four batches, and the decision was granted immediate enforceability.
If you feel unwell after consuming this product, contact your doctor or call the poison control center.
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