SOP on Product Recall and Handling of Recalled Products
Objective : To lay down a procedure for product recall and handling of recalled products
Scope : This Standard Operating Procedure is applicable for recall of drug products and handling of recalled drug products manufactured or marketed.
Responsibility : Head, Quality Assurance/ designee shall be responsible for the coordination of product recall and final disposition of recalled product.
Head, Finished Goods Warehouse/ designee shall be responsible for providing the relevant information to the Head, Quality Assurance and execution of the product recall activity. He shall also be responsible for handling of recalled products as per this SOP.
Manager, Intellectual Property Rights and Legal Affairs/ designee shall be responsible for propagation of the product recall message through mass media, if required.
Head Quality and compliance/ designee shall be responsible for final approval and authorization for the product recall.
Head, Regulatory Affairs/ designee shall be responsible for the correspondence of recall with the Domestic/ Overseas drug authorities.
Product Recall: A system designed to remove the product known or suspected to be defective from the market promptly and effectively.
Product Recall and Review Team: A group comprising heads of Quality Assurance, Production, Quality Control, Marketing, Finished Goods Warehouse, Drug Regulatory Affairs and if required, Head of Pharma Research and/or Head, Clinical Research. Recall and Review Committee is henceforth referred as committee.
Recall Strategy: Planned specific course of action to be taken in conduction of a specific recall which addresses a depth of recall, need for public warnings, and extent of effectiveness of checks for recall.
Procedure : On receipt of any complaint on the product safety, efficacy, purity, identity, etc. the same shall be investigated as per the SOP titled “Handling of Product Complaint.” During the course of investigation and assessment of degree of seriousness of heath hazard to population, if it emerges that the product is defective (or) and if company undertakes a voluntary recall or recall directed by the regulatory body(s), then the below mentioned procedure shall be followed.
Head, Quality Assurance/ designee shall initiate the form ‘Product Recall-Investigation & Disposition by filling product details, name of the committee members (HODs of concerned departments to be provided by Head-QA/ designee) and nature of the product complaint/defect.
Each Product Recall shall be assigned a seven character number PRXX/YY where: PR: Stands for Product Recall, XX: denotes serial number of the product recall i.e.01, 02, 03,…….99 , /: Slash ,YY: Denotes year of product recall i.e.25 for the year 2025, 26 for the year 2026 etc. A new series shall commence at the beginning of New Year. e.g.: A Second product recall for the year 2025 shall be written as PR02/25.
Any batch of a product for which partial distribution has already begun and there is a product defect, the remaining quantity, if any shall be put under HOLD by Quality Assurance till the committee takes a final decision.
Head, Quality Assurance/ designee shall coordinate with other members of the committee for investigation of product recall/defect & degree of health risk involved. Depending on the investigation, the committee proposes that the product shall be recalled or not.
Note: Committee shall constitute the members of business partners (if specified in the technical contracts).
The committee shall ascertain the severity of complaint, level of distribution of the product to be recalled & time frame for product recall. ‘Guideline for Categorization of Defects in Products and Reasons for Recall shall be used as a guideline for ascertaining severity of complaint and time frame for product recall.
Once the product recall has been decided the recall committee shall devise a recall strategy comprising the time required for conducting product recall depending upon the category of the defect. Refer column ‘Recall strategy in the form Product Recall –Investigation & Disposition’.
Recall Strategy: Depending on the product’s degree of health hazard and extent of distribution, the recall committee shall devise a recall strategy. The recall Committee shall specify level in distribution chain to which the recall is to extend. e.g. whether the product recall shall be up to the consumer level, Retailer level, distributor or wholesaler level etc. During the investigation of recall if it is found that product defect is so dangerous as to be life threatening then public announcement shall be made to reach retail outlets, hospitals, medical practitioners, and individuals users by means of mass media.
Final approval and authorization for a product recall shall be obtained from Head Quality and compliance/ designee (In non-availability only), refer form ‘Product Recall- Investigation & Disposition.
Once the product recall has been decided, Head, RA on behalf of company shall inform the drug authorities regarding decided product recall with following details. The contact details of the Drug Authorities, Depots, C&F and distributers shall be maintained. Product Name, Batch No., Batch Size, Manufacturing Date and Expiry Date., Reason for recall.
The distribution records shall be checked / reviewed to list down the name, addresses and contact numbers of customers with quantities distributed to each distributor.
Further distribution, and/or sale of the product shall be stopped immediately once recall has been decided.
All company representatives and outlets in the market to which products have been distributed shall be informed promptly by Head, Finished Goods Warehouse. The list of addresses, phone and/or fax numbers, email contacts inside and outside working hours of all the company representatives and outlets in the market, and delivered batch numbers and quantities of goods delivered shall be maintained by Finished Goods Warehouse.
All the concerned parties shall also be informed by letter to be posted under “Certificate of Posting”. If no reply is received from them within a period of fifteen days, then a reminder of the same shall be sent to them under “Registered Post”.
For country(s) other than India, recall shall be initiated as per the terms agreed with the concerned Marketing Partner(s)/ Regulatory Authority(s).
If required, personnel from intellectual property Rights and Legal Affairs department shall arrange for media coverage including television, telephone, print media, radio, internet, etc for prompt propagation of product recall message.
Recalled products shall be received by Finished Goods Warehouse personnel. Finished Goods Warehouse personnel shall physically verify the details of the recalled products like Product name, Batch No., Mfg. Date, Expiry Date and pack. The product shall be stored in a designated area in the Finished Goods Warehouse while awaiting a decision on further course of action. Remaining stock, if any, of the suspected batch of the product in the warehouse shall also be moved into this secure storage area and entry to the area shall be restricted.
Reconciliation between the delivered and recovered quantities of the product shall be recorded on form ‘Product Recall by Finished Goods Warehouse personnel and approved by Head, Finished Goods Warehouse and Head, Quality Assurance.
The concerned person from Finished Goods Warehouse shall handle the recalled products as per the decision taken by the committee.
In case of product recall, the batch preceding and succeeding the recalled batch shall be investigated e.g. if batch number 58 of product is recalled, then the samples and documents of the batch number 57 and 59 shall be reviewed and proper investigation undertaken.
An internal audit shall be carried out after reconciliation of recalled product to check the effectiveness of the product recall.
Recall committee shall finally review the complete recall operation including all documentation and QA head shall close the recall putting a stamp RECALL COMPLETED on form Product Recall Reconciliation.
A guideline of the product recall and handling procedure ,Flow Chart- Product Recall and Handling of Recalled Products.
Product recall submission, public notification and recall effectiveness shall be recorded by Head, RA.