Products recalled voluntarily or on the advice of FDA and returned to warehouse shall be handled as follows:
1. A responsible person, usually the Head of Quality Assurance, should initiate and coordinate all recall activities.
2. Investigation regarding the correctness of the reported defect should be carried out expeditiously by the Head of Quality Assurance, and who should be supported by Production, Distribution and Sales personnel in carrying out the investigations.
3. Recall action should then be initiated by the Head of Quality Assurance by notifying the top management, giving necessary details, and obtaining their approval for proceeding with the recall.
Extent of a recall i.e. whether at Distributor/Wholesaler level or upto Chemist level should be decided taking into account the nature of defect.
4. The objective of a recall is to discontinue distribution. retail sale of the product and to retrieve concerned stocks from the market. This objective is best served by sending suitable communication to Company's Distributors, Wholesalers, and the Field Staff.
Related: Deviation in Pharmaceuticals
5. Records of distribution should be used for sending the recall notification.
The recall notification should include:
• The product name, its strength, pack size.
• Batch or Lot Number .
• Nature of the defect.
• Action to be taken viz. Immediate quarantine of stocks, instructions to return stocks, complete accounting of the stocks initially received by the party etc.
• Urgency of the action.
6. In case of recall initiated on instruction/advice from Drugs Control Authorities, they should be suitably notified regarding the recall action.
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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