OBJECTIVE:

• To establish a uniform procedure for prompt, efficient, and effective withdrawal or removal of finished pharmaceutical products from the market whenever a quality, safety, or regulatory defect is identified.

• This SOP ensures full compliance with regulatory expectations, providing for coordination, communication, and documentation of all recall activities.

SCOPE:

This procedure applies to all finished pharmaceutical products manufactured, imported, or distributed by the company, including both domestic and export. It covers voluntary recalls, statutory recalls, and regulatory-mandated recalls at wholesale, retail, or consumer level.

RESPONSIBILITIES:

Head Quality Assurance (QA):

• To evaluate recall necessity based on product quality defect or safety risk.
• To authorize initiation of recall; to notify Competent Authorities within 24 hours for Class I recall; and to approve recall closure and destruction.
• To ensure compliance with this SOP,
• To coordinate recall actions, maintain recall documentation, and monitor recall effectiveness.

Head – Regulatory Affairs (RA):

• To liaise with local and international Competent Authorities, issue recall notifications, and provide updates until closure.

Head – Warehouse / Distribution:

• To immediately stop distribution, identify, segregate, and reconcile all affected batches;
• To ensure recalled goods are quarantined.

Head Production / Quality Control (QC):

• To support investigation and provide data on production, testing, and root cause analysis.

Head – Pharmacovigilance (PV):

• Monitor adverse drug reaction (ADR) reports and signal detection data.
• Immediately inform Head QA when a PV signal may require product recall or batch withdrawal.
• Provide ongoing safety update to head RA/QA until closure

Head Marketing / Sales:

• To assist in communication with distributors, wholesalers, and customers and coordinate product retrieval.

DEFINATIONS:

• Recall: Process of withdrawing or removing a product from the market due to defects or potential risks to patient safety.
• Voluntary Recall: Initiated by manufacturer or importer due to identified product quality or safety concern.
• Statutory Recall: Mandated by Drug Regulatory Authority.
• Recall Classification:
  • Class I: Defect may cause serious adverse health consequences or death.
  • Class II: Defect may cause temporary or medically reversible harm.
  • Class III: Defect unlikely to cause adverse health effects.

• Rapid Alert System: Immediate notification to Competent Authorities for serious health risk (Class I).

PROCEDURE:

Recall Initiation and Pharmacovigilance Linkage:

• Recalls shall arise from:
  • • • Market complaints or pharmacovigilance reports indicating safety risk.
      • Post-marketing stability failures.
      • QC/QA investigation outcomes showing contamination, mix-up, or mislabeling.
      • Direction from Drug Regulatory Authority.
• Any such information shall be communicated immediately to management.
• If PV identifies a confirmed or potential safety signal (e.g., unexpected ADR, cluster of reports, death), Designee PV shall immediately notify Head QA.
• Head QA shall assess the severity and decide recall classification (Class I/II/III) within 24 hours (max).
• The decision, rationale, and PV reference number shall be documented in the Recall Recommendation Form.

Regulatory initial and follow up notification:

Class I recalls:

• Head QA shall notify the concerned Competent Authority within 24 hours of the recall decision.
• Progress updates shall be provided every 48 hours or at the frequency directed by the authority until the recall activity and product retrieval are fully completed.
• A formal closure notification shall then be submitted within ten working days after reconciliation is completed.

Class II recalls:

• The initial notification to the authority shall be sent within three working days from the recall decision, followed by weekly progress reports until all affected stocks are retrieved and reconciled.
• The final closure notification and summary report shall be provided within twenty working days after reconciliation and CAPA completion.

Class III recalls:

• The initial notification shall be submitted within seven working days, with monthly progress summaries until the activity is closed.
• The final closure report shall be issued within thirty working days after reconciliation.
• All communications to Competent Authorities shall contain detailed product and batch information, health-risk classification, distribution extent, current retrieval percentage, and a summary of corrective and preventive actions taken.
• The QA department shall retain proof of each communication—such as email acknowledgements, fax confirmations, or official correspondence—in the recall documentation file for regulatory verification and audit readiness.

Communication to Distribution Chain and reminder:

• QA shall issue a Recall Notification Letter to all distributors, wholesalers, and customers through the fastest mode of communication (email/fax/SMS/telephone). The notice shall contain:
• Product and batch details
• Manufacturing and expiry dates
• Nature of defect and reason for recall
• Instructions for segregation and return
• Contact details for recall coordination
• Recipients must acknowledge within 48 hours for Class I or 5 days for Class II/III. If no response is received:
  • 1st Reminder: Shall be sent within 48 hours after non-response.
  • 2nd Reminder: sent after additional 48 hours with copy to Head Sales & RA.
  • Persistent non-responders shall be escalated to the regulatory authority as part of progress report.

 Product Retrieval, segregation and Reconciliation:

• All recalled products shall be labelled as “PRODUCT RECALLED – DO NOT USE” and stored in a segregated, locked quarantine area until further instruction from QA.
• Warehouse shall maintain batch-wise reconciliation record showing:
  • Distributed quantity
  • Quantity received from market
  • Quantity pending response
  • Final reconciled total (≥ 95 % retrieval expected for Class I recall).
•  QA shall reconcile returned quantities with distributed quantities and document any discrepancies.
• Designee QA shall consolidate reconciliation status weekly and share with Head QA.
• Final reconciliation summary shall be annexed to the Recall Closure Report and submitted to Competent Authority.

Investigation and CAPA:

• QA and along with support functions shall perform detailed investigation to determine root cause and evaluate potential impact on other batches within 30 calendar days of recall initiation.
• Corrective and Preventive Actions (CAPA) shall be implemented to prevent recurrence.
• The investigation summary shall be reviewed and approved by the QA before final recall closure.
• CAPA shall be implemented, effectiveness verified, and summary sent to Head QA.
• Where PV signal triggered the recall, PV department shall submit a Safety Corrective Action Report (SCAR) to QA for onward submission to regulatory authorities.

Effectiveness Verification and closure timeline:

• QA shall verify recall effectiveness by confirming product retrieval percentage at each level (wholesale/retail/consumer) and assessing communication adequacy.
•  A Recall Effectiveness Report shall be prepared and approved by Head QA.
•  Closure Timelines shall be as below
  • Class I: within 60 days of initiation
  • Class II: within 90 days
  • Class III: within 120 days
  • Extensions shall require written justification and QP approval.

Recall Closure and Product Disposal:

• When all affected stock has been retrieved and reconciled, a Recall Closure Report shall be prepared by QA and endorsed by Head QA.

• Until recall closure, QA/RA shall continue to provide status updates to the authority at following frequency
  • Class I – every 48 hours
  • Class II – weekly
  • Class III – monthly.
  • Final closure summary shall be officially acknowledged and archived in Recall File.

• Recall Closure Report shall include:
  • Summary of quantities distributed/recalled/disposed
  • Investigation + CAPA summary
  • List of non-responders and follow-ups
  • Authority correspondence copies
  • PV signal reference (if applicable)
  • Final QA certification and sign-off

• Product disposal/destruction shall be carried out under supervision of QA, RA, and local authority representative, with a Destruction Certificate retained.

Recall Numbering System:

• Each product recall shall be assigned a unique sequential Recall Reference Number at the time of initiation to ensure traceability and proper documentation control.
• The numbering pattern shall follow the below structure: PR / YY / DDD. Where:
• PR = Product Recall
• YY = Last two digits of the year in which the recall is initiated
• DDD = Sequential serial number (three digits) starting from 001 for each calendar year
• Example: PR/25/001 → First recall initiated in 2025

Documentation and Records retention policy:

• All recall records shall be maintained for minimum five (5) years from the date of recall closure. Following document retained for mentioned period.
• • • Recall Notification Form
    • Recall Log
    • Recall Effectiveness Report
    • Recall Closure Report
    • CAPA Report
    • Destruction Certificate
    • Additional documents, if any.

Mock Recall:

• To verify system effectiveness, a mock recall shall be performed at least once every two years.
• Results and corrective actions shall be documented and reviewed by Designee QA and Head QA.

REFERENCE:

• EU GMP Part I, Chapter 8 – Complaints and Product Recall
• EU GMP Annex 16 – Certification by a Qualified Person and Batch Release
• WHO TRS No. 986, Annex 3 

RECORDS:

 REVISION HISTORY: