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SOP On Product Recall

  • Objective :To lay down procedure for prompt and effective recall of finished products known or suspected to be defective, from domestic and export market.
  • Scope:This Standard Operating Procedure is applicable to the product recall of the products manufactured at the formulation plant of Pharmaceutical (Company Name ).
  • Responsibility:
  • Quality Assurance :Decision for recall,Reviewing status of recall
  • QA Head : Initiation for product recall,Communication to concerned department,Initiation of investigation,Product Review (current & other manufacturedbatches),Ensuring batch recalled is quarantined
  • Distribution Department: Provide distribution list,Facilitating recall from all distribution points,Ensuring stoppage of further sale & distribution of suspected batches.
  • Manager stores : Storage of recalled goods,Destruction of recalled goods.
  • Accountability: QA Head shall be accountable for implementation of this SOP.
  • Abbreviations and Definitions

SOP:Standard Operating Procedure

QA: Quality Assurance

  • Procedure
    • Any written communication received from complainant (Distributor/ retailer / stockiest/ Field staff / customer / doctor) regarding the defects in product quality (purity, efficacy and any adverse drug reaction) including its physical characteristics, packaging, labeling etc. shall be investigated as per “SOP on handling of market complaints”.
    • Based on the recommendations given in market complaint Investigation, QA Head shall decide for product recall.
    • The product recall could be Voluntary or Forced.
    • NORFLOXACIN & LOPERAMIDE CAPSULE (drugsformulations.com)

Voluntary Recall is done for Products by the manufacturer when any adverse reaction is brought to the notice directly to the manufacturer or when the manufacturer has noticed problems in the product quality or stability.

Forced Recall is done on instructions by the Regulatory Authority when any adverse reaction or untoward incident is reported by the general public, hospitals, physicians or any laboratories.

  • Recall can be classified as:

Class I recall: a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

Class II recall: a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Class III recall: a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

  • QA shall fill up “Product Recall Form” as per Annexure-I. Each product recall form shall be assigned a unique alphanumeric number of 7 characters by QA department.

For example, PR16001

Where, first two characters PR stands for “Product Recall”.

3rd and 4th characters represent the last two digits of year 2016.

The last three characters denote sequential serial number.

  • The form shall be forwarded to QA Head for approval.
  • The reasons and conditions of the product recall and its class shall be discussed by QA Head, Regulatory, Marketing. An action plan shall be prepared by this group.
  • If the product batches to be recalled are from the regulated markets, necessary communication will be sent by QA Head to the respective Regulatory Authority, after consulting Regulatory Affairs.
  • The Product Recall shall be initiated promptly no sooner the decision is taken by QA Head. Necessary communication shall be sent to all concerned within the shortest time period, but not later than 72 hours in case of Class I and Class II.
    • The Distribution record shall be checked by QA Head in consultation with Distribution Department to identify the destinations, the quantities, batch number-wise.
    • QA Head shall advise Distribution department and Marketing department to instruct the distributors and stockists to stop further dissemination and sale of the product batches.
    • The communication can be sent by telephone, email, fax, and any other faster mode. Where required this may also be put on news media, but only in case of Class I recall.

A follow-up on the communication and response to it shall be monitored by QA, Distribution and Marketing department.

  • Necessary arrangements shall be administered by the Supply chain to receive the recalled product batches’ quantities. The returned stock shall be reconciled to the closest quantity of actual distribution.
  • This reconciliation shall consider all unit or pack of batches under recall even from hospital and pharmacy stores. The batch documentation and reconciliation shall be thoroughly scrutinized by competent personnel from QA, Distribution and Marketing departments.
  • In the likelihood of possibility of destruction of stocks in the country of market, the QA Head shall delegate responsibility to the supply chain to do so with the permission of the local Regulatory authority.
  • The returned/ recalled stocks shall be destroyed as per the destruction procedure.
  • All records and communications related to Product Recall shall be properly maintained by the respective departments, such as Distribution department, Marketing department and QA as per Annexure- II. These records shall be reviewed by QA for adequacy and accuracy.
  • The local Drug Control Authority shall also be informed of such recalls by QA.
  • Mock Recall-In order to evaluate the product recall program, periodic mock recalls should be carried out at least once a year. All information obtained during the Mock recall shall be documented on the Recall Log. The mock recall file should include the name, address and telephone number of clients for the lot tested, production records, the inventory, and distribution of lot distributed.
  • Mock recalls are used to determine whether the recall procedure is capable of identifying and quickly controlling a given lot of potentially affected product and reconciling the quantities produced, quantities in inventory, and quantities distributed.
  • A mock recall will identify potential problems and allow personnel to become familiar with recall procedures. If problems are identified in the recall procedures, they should be corrected.
  • All corrective actions and deficiencies shall be documented in the Recall Report.
  • Forms and Records (Annexures)
    • Product Recall Form – Annexure-I
    • Log Book of Product Recall – Annexure-II
  • Distribution
    • Master copy – Quality Assurance
    • Controlled copies – Quality Assurance, Production, Stores, and Quality Control. 
  • History
Date Revision Number
Reason for Revision
00 New SOP


Fungal Diastase I.P 50mg (drugsformulations.com)


                                           Product Recall Form                                                                                                                                 Date:      __________

   1.0    Recall Initiation                   

Product Recall No.:                                     (to be assigned by QA)
1.1 Initiated By                                  
1.2 Product Name:                           Batch No.: Category:
1.3 Batch Size:
1.4 Market:
1.5 Reason for Recall
1.6 Recall Details: Batch number wise

Total Quantities:

Pack sizes:

Distribution record verification:

Distribution destinations:

1.7 Proposed Recall Plan: Mode of communications:

Information to RA and inputs:

Information to Regulatory authority:

Returned Goods Receiving point:

Follow-up results:

1.8 Attachments / Supporting Data (if any):


Initiated by QA Name Signature Date
2.0 Review by Head-QA (comments):
Review by Head-QA Name Signature Date
3.0 QA Review / Approval                 Approved           Rejected
4.0 Implementation of Product Recall
4.1 Dates of Recall communications:

Stoppage of distribution & sale:

Return of Goods:

4.2 Quantities returned and Reconciliation:
4.3 Recall process review done by (names & signatures) QA, Distribution, Marketing:


Review by


Name Signature Date


5.0 QA Review of Implementation & Closure
5.1 Summary Report of Recall:
5.2 QA Comments on Reconciliation:
5.2.1 All Recommendations Fulfilled:             Yes /           No
5.2.2 If No, Justification:
5.2.3 Data Generation Completed:                Yes /           No
5.2.4 If No, Justification:
5.2.5 Can the Product Recall Be closed? :      Yes  /          No
5.2.6 Remarks (if any):
Closure Approved by QA Head Name Signature Date


                                       Logbook of Product Recall

Sr. No Product Recall Report No. Product Name Batch No. Strength & Pack Size Batch Size Mfg date Exp Date Reason for Recall Batch Distribution Details Date of Initiation of Recall Closure of Recall on Qty Recalled Reconciliation Disposal of Recalled Material done on Remarks
Plant Qty

Norethisterone Tablet (drugsformulations.com)


About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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