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Guidelines on Recall

Introduction:

     Recall is an action taken to withdraw/remove the drugs from distribution or use including corrective action for which deficiencies are reported in quality, efficacy or safety. The defective products related to quality includes Not of Standard Quality, Adulterated or Spurious drugs. Safety and efficacy related recalls include serious adverse reactions and death. Recalls also include drugs prohibited under the Provisions of Drugs & Cosmetics Act and also those products for which product licenses are suspended/cancelled. Rapid Alert System is to transmit only those alerts whose urgency and seriousness cannot permit any delay in transmission. Assessment must be made of the seriousness of the defect, its potential for causing harm to the patient or harm to animals (in case of veterinary product), consumers, operators and the environment.

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