HMA MEDICAL LTD Page 1 of 5

Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.

STANDARD OPERATING PROCEDURE
Title: Handling of Product Recall and Mock Recall
Department: Quality Assurance Issued Date: 6th September, 2023
Mandatory Review Date: 10th September, 2025 Effective Date: 11th September, 2023
No.: HMA/QAD/SOP025-04 Supersede: HMA/QAD/SOP025-03

1.0 OBJECTIVE:
This is to lay down procedures for recalling defective products, field correction market
withdrawals and stock recoveries.
2.0 SCOPE:
This procedure is applicable to the withdrawal of defective products from the market by the sales
teams.
3.0 RESPONSIBILITY:
3.1 Managing Director: Approval of recall
3.2 Quality Assurance Manager: For investigation and recommendation for recall and also notify such
recalls to concerned regulatory body
3.3 Production Manager to investigate the reasons for recall jointly with the Quality Assurance Manager.
3.4 Head of Marketing: To monitor and follow up the recalls.
3.5 Recall Team: this is a team responsible for carrying out the recall operation. The team shall be headed
by the National Sales Manager with other members such as; QA/QC Manager, Group Technical
Adviser, Regional Sales Manager for the area of recall, and Production Manager.

4.0 ABBREVIATIONS:
SOP Standard Operating Procedure QC Quality Control
QA Quality Assurance NA Not Applicable

5.0 DEFINITIONS:
Not Applicable
Function Name Designation Signature Date
Compiled by Quality Assurance Executive

Reviewed by Quality Control Manager

Approved by Quality Assurance Manager

Authorised by General Manager

 HMA MEDICAL LTD Page 2 of 5

Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.

STANDARD OPERATING PROCEDURE
Title: Handling of Product Recall and Mock Recall
Department: Quality Assurance Issued Date: 6th September, 2023
Mandatory Review Date: 10th September, 2025 Effective Date: 11th September, 2023
No.: HMA/QAD/SOP025-04 Supersede: HMA/QAD/SOP025-03

6.0 PROCEDURE:
6.1 PRODUCT RECALLS
6.1.1 Any product complaint from consumer, field staff or from Regulatory Agency is referred to
Quality Assurance/Control for investigation.
6.1.2 After completion of investigation and evaluations QA Manager shall be informed to
initiate the recall with the approval of the General Manager.
6.1.3 Based on evaluation, the class of recall will be decided.
6.1.4 Notification to Quality Assurance Manager shall include the following information:
a. Complete identity of the product and accurate explanation of the reasons for
taking the action.
b. Date for the action to be completed.
C. Evaluation of the potential risks
c. Quantities of the product for recall.
d. Level of recall.
f. Extent of Regulatory Agency’s involvement.
g. Any special problems, considerations, complexities etc.
h. Financial implication of the recall action.
i. Recommendation for preventive action.
6.1.5 The Managing Director Shall notify the regulatory Agency in case level of recall is of
type I or II or recalls initiated on instruction / advise from regulatory Agency

Function Name Designation Signature Date

Compiled by Quality Assurance Executive

Reviewed by Quality Control Manager

Approved by Quality Assurance Manager

Authorised by General Manager

 HMA MEDICAL LTD Page 3 of 5

Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.

STANDARD OPERATING PROCEDURE
Title: Handling of Product Recall and Mock Recall
Department: Quality Assurance Issued Date: 6th September, 2023
Mandatory Review Date: 10th September, 2025 Effective Date: 11th September, 2023
No.: HMA/QAD/SOP025-04 Supersede: HMA/QAD/SOP025-03

6.1.6 Head of Marketing and Distribution shall be informed about the recall and necessary
product information. He will stop further distribution and give clear directions to this
effect to all key points in the distribution.
6.1.7 Recall communication shall also seek and obtain information on stocks of product
which is being recalled and confirmation that further distribution and or sale has
been stopped and such stocks are quarantined, by deploying a representative to all
depots, stock list, chemists & hospitals depending upon the level of recall.
6.1.8 If the product defect is CLASS I, it has to be withdrawn within 24hours by sending
intimation and memorandum through the sales representative of the geographical
locations up to customer level, Distributors, Stock list & Hospitals, Chemists and
Customers. Physical recall shall be completed within 72hours.
6.1.9 Head of Marketing / Distribution shall check whether the information has reached all
concerned by making telephone or personnel visits to their locations.
6.1.10 If the product defect is CLASS II, intimation has to be sent to distributors and field
Staff and Distributors should be asked to discontinue the sale of the product batch.
All the field staff shall be informed to collect the affected stock as member of the
sales team receives complaint from affected customer and recall shall be completed
within 10days.
6.1.11 If the product defect is CLASS III, recall of the product shall be within 30days from
distribution outlets and warehouse stock.
6.1.12 Entire stocks of the products, which have to be recalled, shall be collected to Warehouse
and shall be held under strict security.

Function Name Designation Signature Date

Compiled by Quality Assurance Executive

Reviewed by Quality Control Manager

Approved by Quality Assurance Manager

Authorised by General Manager

 HMA MEDICAL LTD Page 4 of 5

Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.

STANDARD OPERATING PROCEDURE
Title: Handling of Product Recall and Mock Recall
Department: Quality Assurance Issued Date: 6th September, 2023
Mandatory Review Date: 10th September, 2025 Effective Date: 11th September, 2023
No.: HMA/QAD/SOP025-04 Supersede: HMA/QAD/SOP025-03

6.1.13 Where appropriate, stocks shall be held till inspection formalities by Regulatory Agency /
Insurance company / Excise authority are completed.
6.1.14 Quality Assurance Manager shall instruct the Warehouse Manager where the material has
to be transferred for disposal if need be.
6.1.15 Destruction shall be carried out under the supervision of production and QA/ QC
Departments’ representatives.
6.1.16 Records of such destruction shall be maintained for a period six months beyond the stated
expiry date.
6.2 MOCK RECALLS
6.2.1 A recall carried out to check the effectiveness of the recall.
6.2.2 Mock recall shall be carried out at least for one product, dispatched for sale where maximum
distributors are involved and details shall be recorded in Annexure II –Mock Recall Form
6.2.3 Mock recall shall be performed for the longest distribution chain at least once in two years.
6.2.4 During mock recall, Perform the traceability for at least, one of the raw materials used in the
batches identified for mock recall.
6.2.5 Mock recall shall be aimed at the following objective:
6.2.5.1 Alert recall team
6.2.5.2 Performing the reconciliation to test product traceability.
6.2.5.3 Test the responsiveness and knowledge of the team operating the recall system
6.2.5.4 To implement any corrective action to improve the recall system.
6.2.5.5 Mock Recall process shall be completed within 30 working days from the date of initiation.

Function Name Designation Signature Date

Compiled by Quality Assurance Executive

Reviewed by Quality Control Manager

Approved by Quality Assurance Manager

Authorised by General Manager

 HMA MEDICAL LTD Page 5 of 5

Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.

STANDARD OPERATING PROCEDURE
Title: Handling of Product Recall and Mock Recall
Department: Quality Assurance Issued Date: 6th September, 2023
Mandatory Review Date: 10th September, 2025 Effective Date: 11th September, 2023
No.: HMA/QAD/SOP025-04 Supersede: HMA/QAD/SOP025-03

7.0 ANNEXURES:
Annexure-I: Recall Form(a)
Annexure-II: Recall Form(b)
Annexure-III: Recall Register

8.0 FREQUENCY:
As at when required

9.0 DISTRIBUTION LIST:

Master copy – Quality Assurance Manager
Controlled copies- Quality Control Manager, Production Manager and Stores executive.

10.0 REFERENCE DOCUMENT:

Not Applicable

11.0 REVISION LOG:

Revision No. Effective Date Reason for Revision
01 August, 2019 Expired
02 August, 2021 Expired
03 August, 2023 Review of SOP format
04 September 2023 Post-Audit SOP

Function Name Designation Signature Date

Compiled by Quality Assurance Executive

Reviewed by Quality Control Manager

Approved by Quality Assurance Manager

Authorised by General Manager

 ANNEXURE I
RECALL FORM(a)
(Ref: HMA/QAD/SOP025-03)
Product Name______________________________________________________________
Reasons for recall----------------------
Batch no--------------------
Mfg. --------------------------
Exp --------------------------
Quantity recovered---------------------

Customer’s Name: __________________________________________________________

Address: ___________________________________________________________________

Reporting Sales Team:

___________________________________________________________________________
_______________________________________________________

Sales Manager’s Report:

___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________

Official Response:
___________________________________________________________________________
___________________________________________________________________________
__________________________________________________________________________

Sales Manager:
____________________________

(Ref: HMA/QAD/SOP025-03)
 ANNEXURE II
RECALL FORM(b)
(Ref: HMA/QAD/SOP025-03)

Section A: Initiation

Recall No: Initiation Date:

Type of Recall:

Complaint Reference No.:

Recall
Class: I II III
(Tick)
Depth of
Recall
Market (Sale/Export): State/Country:

Product Details:

Brand Name: Generic Name:

Batch No. Batch Size Dispatch Qty. Pack Size Mfg. Date Exp. Date

Reason for recall

Initiated by (QA) Name Sign Date

Checked by (Production)

(Ref: HMA/QAD/SOP025-03)
 Section B: Review & Approval of Recall
Comments:

Review & Approval

by Production
Manager Recall: Approved Not Approved
Name Signature Date

Comments:

Review & Approval

by QC Manager
Recall: Approved Not Approved
Name Signature Date

Comments:

Review & Approval

by QA Manager
Recall: Approved Not Approved
Name Signature Date

Comments:

Management
Approval
Recall: Approved Not Approved
Name Signature Date

(Ref: HMA/QAD/SOP025-03)
Section C: Contact details of Recall co-ordination committee

Sr. Designation Name Telephone No. Email address Mobile No.

No.

1. QA Manager

2. Production Manager

3. Warehouse Manager

4. General Manager

5. QC Manager

Any Other:

6.

7.

8.

9.

10.

Details Name Sign Date

updated By
(QA Manager)

(Ref: HMA/QAD/SOP025-03)
Section D: Recall Communication:

Recall communication to be sent to all the stakeholders to whom the product is distributed. If required attach
annexure for more details.

Communicated to Contact No. Communication Means (Phone, Fax, E-

mail, other means)

Communicated By (Sign/ Date):

(Ref: HMA/QAD/SOP025-03)
 Section E: Recall Intimation:
Recall No.: Date:
Part A:
Brand Name Generic Name

Batch No. Batch Size Pack Size Mfg. Date Exp. Date

Quantity Released for Distribution: ______________________________________

Received Quantity from Production: _____________________________________
Location Dispatch Qty. Reference Invoice/ bill No. Invoice Date

TOTAL Not Applicable

Part B (To be filled by the branch / depots/ distribution location)
Name of Branch/Depots/Distribution Location__________________________________.

STOCK DETAILS
Product Name
Batch No.
Pack size
Quantity received
Quantity distributed
Stock Quantity
Please attach the distribution record with signature & stamp
Details given by:
Name:
Signature:

(Ref: HMA/QAD/SOP025-03)
Section F: Reconciliation:
Recall No.: Date:
Brand Name Generic Name
Batch No
Date Name of Branch Quantity Variance Remark
Dispatched Received

(Ref: HMA/QAD/SOP025-03)
 Total
Reconciled By- WH (Sign/ Date): Sign/Date (Verified by – QA):

Verified By (Sign/Date): QA Manager/ Designee

(Ref: HMA/QAD/SOP025-03)
 Section G: Evaluation and Closure of Recall:
Sr. No. Checkpoint Yes No
1. Did all the recipients receive notification of this recall & understood the latter
and followed the instructions?

2. Recall has reached up to the maximum level (If No, give details):
_____________________________________________________________
_____________________________________________________________

3. Did whole distributed batch reconciled successfully?

Summary Report of Recall/ withdrawal:

Recall: Satisfactory Not Satisfactory

Closure Approved By QA Name Signature Date

Manager/ Designee

Note: Recall process shall be completed within 30 working days from the date of initiation.

(Ref: HMA/QAD/SOP025-03)
 ANNEXURE III
RECALL REGISTER
(Ref: HMA/QAD/SOP025-03)

Date Recall Product Batch Class Reason Recall Recall Checked Verified
No. Name No. of for Ref. Closure By By
Recall Recall No. Date

(Ref: HMA/QAD/SOP025-03)