Mock Recall and Drug Product Recall Procedure

Standard Operating Procedure for Mock Recall and Drug Product Recall, The drug product recall is a process of removal or correction of marketed products for the reasons relating to deficiencies in quality, safety, or efficacy, including labeling considered to be in violation of the laws.

SOP for Mock Recall & Drug Product Recall

1.0   Objective :

    • To lay down a procedure for prompt and effective recall (Mock & Drug Product) of finished products known or suspected to be defective from Domestic and International Market.

2.0   Scope : 

    • This SOP is applicable to the recall of unsatisfactory products from the market and Mock Recall trials.

3.0   Responsibility

Recall coordinator : Co-ordinates all recall-related activities
Head QA : Notification to regulatory agencies
: Notification to Qualified Person and importers with the complete investigation and other details as applicable/required.
: Reviewing the effectiveness of product Recall and Mock Recall.
: Preparation of Mock recall report
Head – Distribution : Provide distribution list
: Facilitating Mock Recall from all distribution points ensuring stoppage of further sale and distribution of suspected batch.
Head QC : Provide analytical data related to RM, PM, and Product
: Plan & test the subjected batch/product and conduct   investigation
Head- Export market : Ensuring Recall (product / mock) complying with international & regulatory requirements
Head- Legal : Liasoning with media in case of drug product recalls.
Head store : Proper storage of Recalled products.
: Destruction of Recalled Products

4.0   Procedure for Product Recall and Mock Recall :

    • Definition:
    • The recall is described as the removal of a specific batch /batches of a product from the market due to deficiencies in the quality, identity safety, and efficacy.
    • Type of recall is Voluntary recall and statutory recall.
  • Initiation of Product recall:

    • Recall can be initiated in the following cases but not limited to:
    • If there is a market complaint about the product’s risk.
    • If manufacturers, wholesalers, retailers, and hospital pharmacists report the possible occurrence of health risk.
    • In case the sample failed in analysis tested by National Medicine Laboratories or by private testing laboratories.
    • In case of failure to meet the specification during the shelf life of the products.
    • Head QA shall initiate the recall process for any product.
    • In addition to this, the recall may be initiated by a competent authority e.g. Local drug authority or any other regulatory authority of the export market or qualified person (QP) of the respective market.
    • Investigation of quality defect or reported failure shall be investigated following SOP for “Handling of Market Complaints” & SOP for Corrective and Preventive Actions (CAPA).
    • The investigation shall cover the following but not limited to:
    • Procedure for the handling of the reported quality defect.

    • The determination of the extent of the quality defect.
    • The checking or testing of reference and/or retention samples shall be considered as part of this, and in certain cases, a review of the batch production record, the batch release record, and the batch distribution records (especially for temperature-sensitive products) shall be performed.
    • The impact and risk assessment of reported quality defect or failure shall be performed, based on the severity and extent of the quality defect or reported failure.
    • The decision-making process that is to be used concerning the potential need for risk-reducing actions to be taken in the distribution network, such as batch or product recalls, or other actions.
    • The assessment of the impact that any recall action may have on the availability of the medicinal product to patients in any affected market, and the need to notify the relevant authorities of such impact.
    • The internal and external communications that should be made in relation to a quality defect/reported failure and its investigation.
    • The identification of the potential root cause(s) of the quality defect.
    • Complaints concerning a possible defect are found to be correct and may cause a potential hazard to the consumer or user.
    • Represent a health hazard or suspected adverse event to the consumer or user.
    • Product/Label mix-up which may cause a potential health hazard to the consumer or user.
  • Type of Product Recall:

    • Product Recall is further classified into three Classes-
    • Class-1:

    • A reasonable probability that the use of, or exposure to, a defective product will cause defects which shall be potentially life-threatening or could cause serious health consequences or death to the user, following are the examples but not limited to:
      • Product not meeting the regulatory specifications.
      • Mix-up or use of wrong primary packaging materials.
      • Adverse drug reaction.
    • Class-2:

    • The use of, or exposure to, a defective product which may cause temporary adverse health consequences or illness of user, following are the examples but not limited to:
      • Missing or incorrect information (leaflets or inserts)
      • Physical changes in products such as discoloration or precipitation.
    • Class-3:

    • The use of, or exposure to, a defective product is not likely to cause any adverse health consequences or not cause a significant hazard to the health of the user, following are the examples but not limited to
      • Faulty overprinting e.g. missing or wrong batch number or expiry date.
  • Level of Product Recall : 

    • Based on the above classification level of recall shall be decided
    • Level 1:
    • Recall shall be done up to Wholesalers, C&F agents, Hospitals, Government Institutions (it may be done in case of class-3)
    • Level 2:
    • Retail outlets, Doctors, Nurses, Pharmacists (it may be done in case of class-2 or class-3 based on the risk)
    • Level 3:
    • Up to Patients level (it may be done in case of class-1 or class-2 based on the risk)
    • Investigation :

    • Detail investigation shall be carried out in case of reported quality defects/process failure/failure to meet the specification limit during the shelf life.
    • The action shall be taken immediately after confirmation of failure.

Related: SOP for Investigation Tools used in Pharma

    • The action plan shall be prepared as per the risk of failure and accordingly class of recall and level of recall shall be defined.
    • During investigation Refer to-
      • Product development data,
      • Specification and Test procedure for Raw Materials,
      • Finished Products,
      • Batch Production Records, and
      • Stability Data of suspected batch on an immediate basis.
    • Analyze the retained samples of the finished product and raw material used for manufacturing the batch but not limited.
    • These data shall be readily available to the recall committee.
    • In the case of the suspected batch, take action promptly depending upon the degree of hazard and extent of distribution.
    • Head QA shall collect the information of the suspected batch from the electronic system and distribution information record.
    • Head QA is the coordinator for Recall related activities and is responsible for the execution of recall and will share investigation and other related data as required by any authority/CG/QP etc.
    • The coordinator shall initiate a meeting with Recall Co-ordination Committee members (RCC).
    • Details of Recall Co-ordination Committee members are given in Annexure III.
    • The Recall Co-ordination Committee shall evaluate all known information on the nature and extent of the reputed health risk and shall take into account but not limited to the following factors:

      • Whether any disease or injuries have already occurred from the use of products.
      • Assessment of hazard to various segments of the population. e.g. children, surgical patients, etc.
      • Assessment of the degree of seriousness of the health hazard to which population at risk would be exposed.
      • The consequences assessment (immediate or long term) of the occurrence of a hazard.
      • Assessment of the likelihood of occurrence of a hazard.
    • The risk assessment shall be done as per the SOP for Quality Risk Assessment to identify the severity of risk involved.
    • The regulatory authorities shall also be informed in situations in which no recall action is being proposed for a defective batch because the batch has expired (such as with short shelf-life products.)
    • Recall operations should be capable of being initiated promptly and at any time.
    • In certain cases recall operations may need to be initiated to protect public health prior to establishing the root cause(s) and the full extent of the quality defect.
    • Rework for the recall products shall be done after discussion with relevant competent authorities and shall be recorded.
    • Activities pertaining to the recall of the product shall be recorded until closure and a final report issued.
    • The reconciliation shall be done between the delivered and recovered quantities for the product as per Annexure VIII.
  • Notification procedure for Product Recalls:

    • Head QA shall send a Notification for recalls to the Head Distribution / Designee or Head- Export (in case of the export product)- Refer Annexure-I.
    • Head Distribution / Designee shall contact all the key persons in the distribution chain (Refer to Annexure V & VI) through oral communication (Mobile phone, contact number) and or Fax/ E-mail.
    • Based on the severity and potential risk, the following notification & communication methodologies will be used:
      • Notification A:

      • It is applicable for Critical Market Complaint Notification and acknowledgment of receipt of Notification of recall, the recall shall be initiated within 24 hrs, this notification is applicable in case of a class-1 recall. In this case, the recall shall be done up to Level 3.
      • Notification B:

      • It is applicable for Major Market Complaint Notification and acknowledgment of receipt of Notification of recall, the recall shall be initiated within 48 hours,
      • This notification is applicable in case of a class-2 recall.
      • In this case, the recall shall be done up to Level 2.
      • Notification C:

      • It is applicable for Minor Market Complaint Notification and acknowledgment of receipt of Notification of recall, the recall shall be initiated within 5 days,
      • This notification is applicable in case of a class-3 recall.
      • In this case, the recall shall be done up to Level 1.
    • In the case of the Export market, product recall shall be initiated in consultation with the Ministry of Health & local agents of the respective country.
    • Public Warning:

    • In case of severe health hazards, Head – Legal shall issue a public warning through general News media and or professional trade or to a specific segment of the population such as physicians, hospital,s etc and alert the public that the said product recalled presents a serious hazard to health.
    • Head QA shall also intimate to the Drug authority/ regulatory agency/ PL.
    • Appropriate market-specific risk-reducing actions should be developed and discussed with the concerned competent authorities, if proposed recall action may affect different markets in different ways.
    • Head QA, Export, and Distribution shall evaluate the effectiveness of the arrangement for specific recall on daily basis for recalls for severe risk, once in 3 days for moderate and once in a week for low risk, once the recall is ordered.
    • After Receiving the Recall Product :

    • Received batches and Physician samples (If any), reconcile the recalled stock & ensure that all units or pack of Batches have been recalled even from Hospital & Pharmacy Stores.
    • Verify the Batch Documentation & reconciliation.
    • Store them in a specific space, labeled as “Recalled Products” in Store under Lock & Key with proper authorization.
    • Maintain a Register indicating all details as per Annexure-IV.
    • Submit details of Recall Status of Stock Recalled from Stockiest / Hospitals and result of Retained Sample to local Drug Authority and other Regulatory Agencies.
    • Keep all recalled Products till officially disposed-off.
    • Prepare a detailed report & submit to Local Drug Authority and or other Regulatory Agencies, with a request for permission of the Destruction of the Recalled Products.
    • Destroy recalled Products in presence of Local Regulatory Authority If required.
    • Receive certificates regarding destruction & keep the records indicating termination of a product recall.
    • Impact Assessment :

    • If the reason for a drug product being recalled implicates associate batches, plan an investigation for those batches, and identify other batches to be recalled.
    • Investigate the recall through CAPA SOP if the problem was due to material, manufacturing, environment, analytical facilities, or human Error,
    • Prepare an action plan for Preventive & Corrective actions to rectify the system. If the problem is associated with external factors, adequate and possible controls required to be employed.
    • Send the action plan to all concerned departments & Head QA shall ensure that all action is taken within the stipulated time frame.
    • Trend analysis and tracks of all the recall exercises are made at the end of the Year.
    • Refer Flow chart (Annexure-II) for a better understanding of SOP.
    • The effectiveness of the arrangements for recalls shall be periodically evaluated by means of mock recall.
  • Recall Procedure for European Market:

    • Procedure for Classification, Notification, and type of recall will remain the same as described above.
    • However, some further clarity with respect to the European market is described below.
    • Based on the nature of complaint/reported failure/Quality defects, potential risk, health hazard, consideration shall be given to the concerned regulatory authorities/CG/PL/ QP/MA, as to how far into the distribution network for recall action.
    • The concerned regulatory authorities/CG/PL/ QP/MA shall also be informed in situations in which no recall action is being proposed for a defective batch because the batch has expired (such as with short shelf-life products).
    • Rapid alert system:

    • In case of a severe health hazard, the rapid alert shall be initiated parallel to public warning in-line with the applicable notification (A, B, and C timeline) to make sure that information is conveying to end-user i.e. patient.
    • A mail communication shall be done to all respective authority’s representatives as per the timeline list of QP/authority contacts shall be referred for this communication.
    • All concerned regulatory authorities should be informed in advance in cases where products are intended to be recalled.
    • For very serious issues i.e. those with the potential to seriously impact patient or animal health, rapid risk-reducing actions such as a product recall may have to be taken in advance of notifying the regulatory authorities/PL/ QP.
    • In the case of export, Head- export shall notify all competent authorities in respective countries and the agent/importer where the product has been shipped.
    • It shall be informed to the country representative/agent/importer as soon the decision for the recall is taken.
    • A list of contact details of Qualified Person, MA, and importer shall be maintained separately product-wise.
    • In case of export product shall be destroyed in the exported country in the presence of local regulatory authority if required or in the presence of representative/importers if required.
  • Mock Recall Trial Test

    • Carry out this test once in a year and shall be covered both within office-hour situations as well as out-of-office hour situations.
    • If any product is actually recalled as per the above-mentioned procedure this year, there is no need to carry out mock recalls as the effectiveness of the arrangements of recall procedure shall be established from the records of the actual recalled product.
    • If no actual product recall is made within a year, QA Head shall discuss it with the core committee person and take approval from senior management.
    • After approval QA head shall initiate the mock trial test mentioned below.

      • QA Head shall select any batch of any finished product which should be a fast-moving item having the farthest distribution.
      • The level of recall shall be assigned as per procedure (described under product recall) before starting the Mock recall activity.
      • The batch selected shall have been distributed up to retail outlets.
      • Information shall be given to Senior Management regarding the mock recall test.
      • The whole activity shall be kept confidential and the distribution people will not come to know that this is a mock recall.
      • This will be informed to them at a later stage e.g. after completion of mock recall activity.
      • After selecting of product and batch, QA Head/ designee shall collect dispatch details from electronic software and collect it in the below format.
Date Quantity Ref. Doc. No.
    • After receiving dispatch details QA Head/ designee shall collect the distribution detail of this batch as per the below format from Distribution Head / Marketing Head for Domestic. Govt. supply, Physician as well as Export supply)
Sr. No. C & FA/ Depot Name Quantity Dispatch Details Contact Person Email/ Phone
    • After receiving the distribution detail, as per the above format QA Head or his designee shall reconcile from the distribution head or Marketing head as per the below format:
Sr.     no. C & FA/ Depot Name Dispatch Quantity (Nos) Stock Status (Nos) Sold By depot (Nos) Break Up of Depot sale (Nos) Sold to


    • Distribution Head and/or Marketing Head (domestic and/or export) shall arrange stock statements from all stakeholders as per the above format.

    • Head-QA/Designee shall record this intimation in Product Recall Register wherein he/she shall write Mock Recall in Recalled Number, In the column of product Name, with product name on which we perform Mock recalled and reason for Recall column mention to perform Mock Recall to verify the effectiveness of the recall.
    • This exercise to be performed only to verify the effectiveness of recall but actual product recall not to be performed.
    • After receiving stock statements from all stakeholders, Authorized QA personnel shall fill up Annexure-VII of Investigation report of Mock recalled and hand over the same to Head QA for his review.
    • The Mock Recall is considered to be successful if all the records are accurate and the tracing back to the stockiest level is completed.
    • Head QA shall review the Investigation report of Mock Recalled and give his remarks and acknowledge the same and submit to Director.
    • If any deficiency observed in the documents/records of any department shall be communicated in writing as well as discussed with the respective head of the department.
    • After successful completion of Mock Recall, Head QA shall circulate the report to distribution Head as well as to senior management and the same shall be recorded.

5.0   Reference – SOP for Mock and Product Recall :

    • Revise Schedule M
    • Volume 4:   EU Guidelines to Good Manufacturing Practice Medicinal Products for
      Human and Veterinary Use, Chapter 8 Complaints, Quality Defects, and Product Recalls
    • PIC/S “Guide to Good Manufacturing Practice for Medicinal Products Part I

6.0   Glossary :

QA : Quality Assurance RC : Recall Committee
RCC : Recall Co-ordination Committee CAPA : Corrective and Preventive Action
MA : Market authorization QP : Qualified Person
PL : Product license EU : European Union
PIC/S : Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme

7.0   Annexure – SOP for Product / Mock Recall :

Annexure – I: Format for Notification of Product Recall

Recall No.                                                                                   Date:
1.    To:
2.    Product Recall Notification
3.    Level of recall
4.    Product:
5.    Brand / Trade Name: 6.    Generic Name:
7.    Dosage Form: 8.    Strength:
9.    Batch No.: 10.  Manufacturing Date:
11.  Expiry Date: 12.  Packaging information:
13.  Recall Coordinator :      Name:     24 Hrs. Telephone No.:
14.  Details of Defect / Reason for Recall :
15.  Information on distribution including exports (the type of customer, e.g. Export/ Sale/PS/Institution Supply)
16.  Notification (for the export market, if applicable) approval from regulatory authority/PL/QP taken ?:    Yes / No/ Not Applicable
17.  Site ( Location) of return of recall batch :
18.  Contact person (Site):                            24 hrs. Telephone No.:
Sign : Date: Time:

Annexure-II: Mock/Product Recall Process flow chart

Product-Mock Recall Flowchart

Annexure – III: List of Recall Committee Member

Sr. No

Responsible  Person Phone No. Mobile No. Fax No.


Annexure-IV: Product Recall Logbook.

Sr. No.

Recall No. Name of Product Batch No. Reason for Recall Maintained By


Annexure – V: Contact details of Domestic Distribution Network




Annexure – VI: Contact details of International Distribution Network

Sr. no. Country Party & Address Contact person

Contact Details

Annexure-VII: Investigation Report – Mock Recall

  1. Information / Reason for Recall:_____________
  2. Information / Reason received from & Date (if applicable):……………
  • Details of the product:
Product Batch No. Mfg. Date Exp. Date Pack Batch Size


Recall Notifications:                 A  (     )                       B (     )                           C (     )

Level of Recall:                                    1 (     )                         2  (     )                           3 (     )

Complaint Sample (s):               Received  (     )   Not Received (     )                NA (     )

  1. Observation and Analytical findings (if applicable):-


  1. Complaint Sample:……………………………………………………
  2. Control samples:………………………………………………………


  1. Review of Batch Manufacturing record:-


  1. Human Error: …………………………………
  2. Machine Error …………………………………
  3. Process Error …………………………………
  4. Material Related …………………………………


  1. Observation and Remarks:- …………………………………


  1. Reconciliation Details from Distribution: …………………………………


  1. The number of units received from packing:……………………………
  2. Qty. of units dispatched:…………………………………………
  3. The number of units in stock in the warehouse:……………………………..


  1. Name, Signature of the Recall committee members:
Name Designation Signature Date
. . . .
. . . .
. . . .

Annexure – VIII: Template for the reconciliation of the delivered and recovered products.

Product Name : Date of initiation of recall  :
Batch Number : Manufacturing Date :
Market : Expiry Date :



Suppliers Name & Address Quantity Received Total Quantity Received by (Sign/Date)


Annexure – IX: List of Qualified persons

Sr. No

Name of Qualified person

Address and Telephone number of Qualified person


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