Product Recall

CONCEPT PHARMACEUTICALS LTD.
Khasra No. 104, Asaf Nagar,Roorkee

STANDARD OPERATING PROCEDURE
Department: Quality Assurance PAGE : 1 OF 18
Title: “Recall” Procedure For Marketed Product(S). SOP No.: CPLR/SOP/QA/024

Revision No.: Nil
Supercedes Version No.: NA Effective Date:
Review Date:
1. Purpose: This procedure describes Administration and management of product recall. Recall of
a medicinal product may be necessary for one or more of the following reasons, but not limited
to –
 Dangerous contamination of the medicinal product that was not detected prior to batch
release.
 Mislabeling (one product labeled as another).
 Wrong labeling (correct product name on the label, but other details incorrect).
 Failure to meet shelf life specification.
 Discovery of a previously unknown serious adverse effect caused by the medicinal product.
2. Scope: This procedure is applicable for all products manufactured at CPL Roorkee.
3. Responsibility:
It is the responsibility of Q.A.Head to arrange for product recall in coordination with
Distribution In-charge/ Export Department. Q.A.Head decides further actions on the returned
goods by consulting government regulatory authorities – Drug Control Authorities like FDA
(Food and Drugs Administration).
4. Definitions: Nil.
5. Procedure:
5.1. Recall is an action to resolve a problem with therapeutic goods for which there are established
deficiencies in quality, efficacy or safety.
5.2. Product may be recalled voluntarily if there is an evidence or doubt that use and continued presence
of the batch/s of product on the market present a risk to the health of the user or products may be
recalled on the advice of regulatory agencies.
5.3. Site QA Managers may advice voluntary product recall as per the site SOP regardless the site is an
API manufacturing unit or drug product manufacturing unit. The QA head shall send circular
(Annexure-I) to all concerned.
5.4. Controller QA shall be responsible for overall execution and co-ordination of all product
recalls.
5.5. Recalls are classified as follows.
Prepared by Checked by Approved by
Name
Designation
Sign.& Date

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Class I : Class I recalls occur when products are potentially life-threatening or could cause a
serious risk to health.
Examples of class I Defects
 Wrong product (label and contents are of different products)
 Correct product but wrong strength, with serious mechanical consequences.
 Microbial contamination of sterile injectable or ophthalmic product, Contamination-
microbial spoilage.
 Chemical contamination with serious medical consequences.
 Mix up of some products with more than one container involved.
 Wrong active ingredient in a multi-component product with serious medical
consequences.
Class II : Class II recalls occur when product defects could cause illness or mistreatment,
but are not falling under class I.
Examples of Class II Defects
 Mislabelling e.g. wrong or missing text or figures.
 Missing or incorrect information –leaflets or inserts
 Microbial contamination of non-injectable, non-ophthalmic sterile product with
serious medical consequences.
 Chemical/physical contamination (significant impurities, cross contamination,
particulates)
 Mix up of product in containers
 Non-compliance with specification (e.g. assay, stability. Fill/weight).
 Insecure closure with serious medical consequences (e.g. cytotoxics, child resistant
containers, potent products)
Class III : Class III recalls occur when products may not pose a significant hazard to health,
but withdrawal may be initiated for other reasons.
Examples of class III Defects
 Faulty packaging e.g. wrong or missing batch number or expiry date.
Name
Designation
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 Faulty closure system.

 Dirt, or detritus, particulate matter.
 Class I or Class II recalls are considered to be urgent safety-related recalls. Class III
recalls are considered to be routine non safety-related recalls.
5.6. The Controller QA shall receive all details of product recall and shall refer it to Recall Co-
ordination Committee consisting of Technical Director, President - Global Regulatory
Management, heads of – site Quality Assurance, Sales and Marketing, Distribution,
Warehouse and Production. Technical Director shall approve all the decisions of the Recall
Co-ordination Committee.
5.7. After consultation with the technical director, the Recall Co-ordination Committee should
decide the extent of a recall taking into account the nature of defect or as per the directive
issued by regulatory agency.
5.8. Recall Co-ordination Committee shall send recall advice to distribution manager and
also informed to J&J before public announcement as per J&J quality agreement.
5.9. Within 24 hours of receipt of the advice, the distribution manager in co-ordination with
regulatory affairs manager should initiate recall from the all stockists up to the level of
retailers. Suitable speedy communication should be sent immediately to all of them
specifying the product name, batch number and manufacturing date of the batch to be
recalled asking them to stop sale of the batch at once.
5.10. Records of distribution should be used for sending the recall notification. The recall
notification shall seek and obtain information on stock of the product which is being recalled
and confirmation that the further distribution and / or sale has been stopped and such stocks
are quarantined. Recall form (Annexure-II) shall be documented with all required details by
C&F agent and shall be submitted to Manager Distribution.
5.11. The recall notification should include:

A. Product name and pack size.
B. Batch No.
C. Actions to be taken - immediate quarantine of stocks, instructions to return the
stock, and complete account of the stocks.
D. Urgency of the action. (For immediate actions persons to be contacted and their
contact details have been included in Annexure IV)
5.12. In case of local sales, all the concerned branch offices should be given required details of

Name
Designation
Sign.& Date

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recall and asked to ensure complete recall from their administrative area. Similarly, in case
of export, all sales and administrative offices abroad and agents abroad should be asked to
ensure complete recall by giving all the required details of distribution.
5.13. On receiving the recall notification, it shall be the responsibility of all concerned persons
including the end user, to ensure complete stoppage of distribution / sale / use of the product
being recalled.
5.14. In case of recall initiated on instruction / advice from Drugs Control Authorities, they
should be suitably notified regarding the recall actions.
5.15. The recall coordination committee shall meet regularly to assess and review the status of
recall.
5.16. All activities and actions related to drug recall should be documented by site Quality
Assurance Manager.
5.17. Regulatory affairs department shall liaise with regulatory agencies for approval on
appropriate disposal / destruction of recalled product.
5.18. Upon completion of products recall, a written summary should be prepared to include the
following:
a. The rationale for and basic cause of the recall.
b. The effectiveness of the recall.
c. Corrective actions to prevent recurrence.
d. Disposition of product recalled
5.19. Recalled product shall be destroyed ( if required) with documenting Destruction Approval
Form (Annexure-III) and approval from all concerned person. This summary report should
be circulated to all key production and other concerned personnel by the Quality Assurance
Manager.
5.20. Recall coordination committee shall finally review the complete recall operation, including
all documents and close the recall as “recall completed”.
5.21. The effectiveness of the arrangement for recall should be tested and evaluated once in two
years by conducting mock recall. The mock recall should be conducted for any one product
which has got distributed up to C & F agent, distributors. Customers shall be informed about
mock recall through a letter (Annexure-VII). Effectiveness of the mock recall will be studied
and documented.
Recall Procedures For Overseas Countries and ANDA Products.

1. In case of decision arrived at to recall of products in overseas market, either due to
local regulatory authorities or complaint from market, the holder of the marketing
authorization will communicate to President – Global Regulatory Management.
Name
Designation
Sign.& Date

Revision No.: Nil
Review Date:
President – Global Regulatory Management will inform the details to Recall Co-
ordination committee consisting of Technical Director, Controller QA, Site QA
Manager and site Production Head. Necessary investigation including report on
reanalysis of product if required will be compiled by Controller QA and will be
presented to Recall co-ordination committee. The findings will be discussed and a
report on conclusion of findings will sent to holder of the Marketing authorization to
complete necessary actions for product recall.
2. Quality Assurance Manager (Site) should investigate the problem in detail to find
out the possible cause for the recall. The production can be suspended till the
product problem is solved.
3. All recall forms, destruction records, circular copies; intimation letters to legal authorities
along with their approval should be filed separately in Quality Assurance Department.
4. Recall in Overseas countries should meet respective local regulatory requirements.
5. The decision of recall the products in overseas market vests with the company
holding marketing authorization. Once the decision to recall the batch has been
taken, the company holding marketing authorization will inform CONCEPT of any
action that is required. The responsibilities to effectively complete the recall and
giving response to local FDA authorities should be fulfilled as listed in the quality
agreement between holder of the marketing authorization and Concept
Pharmaceutical Ltd.
6. If any product batch manufactured for overseas party and found out of specification
data during internal quality checks (e.g. stability studies, physical observation study
of retain sample), inform to overseas agent. (to initiate the recall of the marketed
product batch)
5.22. Voluntary Recall of Goods by the company.

Evidences that require to be identified and evaluated as potential for recall would be -
 Advise by Regulatory authority.
 Product complaints by customer.
 Product defects during product quality review.
 Stability failure, OR
 Any event that can potentially impact negatively on the drug identity, strength,
quality, purity and safety of the product

Name
Designation
Sign.& Date

Revision No.: Nil
Review Date:
5.22.1. Determine the urgency of the recall based on the test results and probable impact
on the consumers.
5.22.2. Intimate H.O. about the case and communicate to Head of Distribution/ Export In-
Charge to arrange for product recall. (Formats for recall enclosed).
5.22.3. Distribution In-Charge/ Export department Head shall immediately inform the
agency to which goods are distributed /exported and ask for immediate stoppage
and distribution of the batch under subject and its recall. Distribution In-
Charge/Export department Head ,after receipt of the distribution details shall ask
sub-depots, distributors for returning the said goods from various stockists,
agencies, hospitals, retailers, etc.
5.22.4. Use any or all the facilities like phone, cell phone, fax, E –mail to get urgent recall.
If required television and radio announcement should also be done.
5.22.5. Receive the recalled goods from the agency. The receipt of such goods must be
through main depot after completion of all regulatory requirements w.r.t. Customs, etc.
5.22.6. Ensure that the returned goods are properly supported with all relevant documents
like name and address of the distributor from which the goods are returned,
invoice number, batch number, etc. Keep the recalled goods in separate designated
area under lock and key.
5.22.7. Reconcile the dispatched goods and returned goods. Find out the areas from where
goods are not received, reconfirm for the consumption of goods in those areas.
5.22.8. Considering all technical aspects & nature of complaint, Q.A.Head shall decide
regarding reprocessing of the same or destroy the goods as per the SOP in
presence of QA and Stores personnel.
5.22.9. Maintain the destruction record of the returned goods.
5.23. Forced Recall of Goods.

(Applicable when the regulatory authorities ask for product recall).
5.23.1. Communicate to Distribution In-Charge/ Export Department to arrange for product
recall. (Formats for recall enclosed)
5.23.2. Distribution In-Charge/ Export department Head shall immediately inform the
agency to which goods are distributed /exported and ask for immediate stoppage and
distribution of the batch under subject and its recall. Distribution In-Charge/Export
Name
Designation
Sign.& Date

Revision No.: Nil
Review Date:
department Head ,after receipt of the distribution details shall ask sub-depots,
distributors for returning the said goods from various stockiest, agencies, hospitals,
retailers, etc.
5.23.3. Use any or all the facilities like phone, cell phone, fax, E–mail to get urgent recall.
If required television and radio announcement should also be done.
5.23.4. Receive the recalled goods from various distributors. The receipt of such goods must
be through main depot after completion of all regulatory requirements w.r.t.
customs, etc.
5.23.5. Ensure that the returned goods are properly supported with all relevant documents
like name and address of the distributor from which the goods are returned,
invoice number, batch number, etc. Keep the recalled goods in separate designated
area under lock and key.
5.23.6. Reconcile the dispatched goods and returned goods. Find out the areas from where
goods are not received, reconfirm for the consumption of goods in those areas.
5.23.7. Consult regulatory authorities / drug controlling authorities before initiating the
destruction of the goods. Destroy the goods as per the SOP in effect in presence of
Q.A. personnel and Stores personnel. Intimate the regulatory authorities about the
process.
5.23.8. Maintain the destruction record of the returned goods.
Mock recall exercise (mock drill):

1. A mock recall exercise will be conducted every two years.
2. This recall is only a drill & not actual product recall.
3. Head QA along with Manager warehouse, regulatory affairs dept., and business
development depts., will be involved in such mock exercise.
4. The mock recall will be done as described below :

 Mock recalls are conducted to know how effectively the recall can be done/
retraced / called back, in case of product recall.
 Such exercise will be conducted on the batch which is one year old i.e.
manufactured one year ago, from date of recall exercise.

Name
Designation
Sign.& Date

Revision No.: Nil
Review Date:
 The exercise will be done by Head QA with the help from Manager Regulatory
Affairs, Manager Warehouse, Manager Business development, Manager
Marketing
 The details viz. Product name, strength, B. No. & Quantity dispatched will be
collected from warehouse, for which the mock recall is to be conducted.
 These details will be given to Manager Regulatory affairs, who will inform the
Manager Marketing
 The concerned Marketing Manager responsible for Mock exercise will inform
and explain to the drug regulatory body about the mock exercise.
 After approval from Drug authority, the Marketing Manager & his team will
inform all stockist & pharmacist to send the stock available at their end.
 Information from Pharmacist / stockist should be available to QA within 48 hrs.
 After receipt of stockist & pharmacist’s stock information, same data will be sent
to Marketing department, to check the data correctness.
 Manager Regulatory & Head QA will jointly review the stock data, against
the dispatched quantity. Variances in the stock will be discussed and
addressed to the management.
 Entire procedure of mock recall exercise will be discussed with Marketing,
Regulatory, QA and the site head for any improvement in implementing an
effective recall system.
 The activity will be documented and a report will be generated.
6. Abbreviations:
SOP Standard Operating Procedures
QA Quality Assurance
CPLR Concept Pharmaceuticals Limited Roorkee
HO Head Office
FDA Food and Drugs Administration
Name
Designation
Sign.& Date

Revision No.: Nil
Review Date:
7. Attachments:
Annexure-I : Circular
Annexure-II : Product Recall Initiation Form
` Annexure-III : Destruction Approval Form
Annexure-IV : Details Of Persons To Be Contacted On Urgent Basis For
Products Recall In India
Annexure-V : Flow Chart For Product Recall Procedure
Annexure-VI : Letter to customer
Annexure-VII : Summary report of product recall
8. References: Nil.
9. Revision History:
Edition No. Date of Preparation / revision Reason for Revision
01 Original issue
02
10. Distribution Record:
CONTROL COPY DISTRIBUTION RECORD

Name
Designation
Sign.& Date

Revision No.: Nil
Review Date:
ISSUED TO NO. OF ISSUED BY/ RECEIVED RETRIVED RETRIVED COPY

DEPT. COPIES ON BY/ON BY/ON DESTROYED
BY/ON
ANNEXURE-I
Page No. : 01 of 01
CIRCULAR
To,
C&F Agent
Sub: Withdrawal of Product ……………………………, Batch No……………………

Name
Designation
Sign.& Date

Revision No.: Nil
Review Date:
As we are withdrawing Product …………………… Batch no………… from the market, you are instructed
to stop further sale and distribution of the batch with immediate effect.
Recall total quantity of the above referred product batch from the market being supplied by you. Kindly
arrange to send details of total stock of the product batch currently available with you and also received from
the Stockist to the Manager Distribution at our Corporate Office in fax within 72 hours from the date of
receipt of this circular.
Arrange to return such stocks within 7 days at the address given hereunder:
From:
The QA Head,
ROORKEE.
Signed By: ________________
CPLR/ QA/024/F01-00
ANNEXURE II
Page No. : 01 of 02
PRODUCT RECALL INITIATION FORM
Date:………………….

Name
Designation
Sign.& Date

Revision No.: Nil
Review Date:
To Recall Committee Ref. No. Date
From Site QA & QC

Name of the product:
Batch No. Mfg. Date Expiry Date:
Manufacturing Location: Pack Size Batch Size Dispatched quantity
Type of Recall:  Class I  Class II  Class III  Voluntary
Reason for Product Recall:

___________________________________________________________________________________________
______
__________________________
Sign / Date:
___________________________________________________________________________________________
______
Approval of Product Recall by Recall Committee:
___________________________
Sign / Date:
If approved, forwarded to Distribution Manager
ANNEXURE II
Date: ………………… Page No. : 02 of 02

To: C & F Agents / Distribution / Retailers
From: Manager Distribution
Code No. : Name:

Address:

Name
Designation
Sign.& Date

Revision No.: Nil
Review Date:
Contact Number:
Product Details:
Product: Mfg. Date

Batch No: Exp. Date:
Product:
(I)
Distribution details:
Sr, Challan No. Date Pack Size Quantity in Units
No.
TOTAL QTY. (A)

(II)
Total quantity received from the C & F Agents / Distribution / Retailers
Sr, Challan No. Date Pack Size Quantity in Units
No.
TOTAL QTY. (C)
___________________
Head Quality Assurance
CPLR/ QA/024/F02-00
ANNEXURE- III
Page No. : 01 of 01
DESTRUCTION APPROVAL FORM
Name of the Product :
Batch no : Mfg. Dt.: Exp. Dt.:

Name
Designation
Sign.& Date

Revision No.: Nil
Review Date:
Total Qty. Received from C&Fs : Date:

(To be destroyed)
Reference for the Recall:
Reason for Recall :
Name of Challan no. Date Pack Qty.

C& F
TOTAL
Destruction Approved by : Director:
Destruction Procedure :
Destroyed in presence of : Date:
Godown In-charge: ___________________ QA Head: ___________________
CPLR/ QA/024/F03-00
ANNEXURE IV
Details Of Persons To Be Contacted On Urgent Basis For Products Recall
In India
Page No. : 01 of
Name :
Designation : President – Global Regulatory Management

Name
Designation
Sign.& Date

Revision No.: Nil
Review Date:
Address : CONCEPT Pharmaceutical Ltd

Khasra No. 104, Asaf Nagar, Roorkee
Telephone : +91 9359327250
Mobile : +91 9967966934
E-mail : yugin@conceptpharma.com
In USA (For ANDA Products)
Name : Frederik Defesche
Designation : President– Custopharm,

Address : Inc.
1902 Wright Place
Suite 200
Carlsbad CA 92008
Telephone : (760) 481-7811; Fax:(760) 301-0048
Mobile : ---
E-mail : fdefesche@custopharm.com
CPLR/ QA/024/F04-00
ANNEXURE V
Page No. : 01 of 01
FLOW CHART FOR PRODUCT RECALL PROCEDURE
Request for Product Recall
Regulatory Affairs Department Technical

Director
Recall co-ordination Committee
Quality Assurance
Sales and
Distribution Warehouse and
Marketing Production
Name
Designation Documentation of entire
recall procedure
Sign.& Date

Revision No.: Nil
Review Date:
Recall from
Intimation to Stockist/
all concerned Retailers
Export
Circulation to Key Local
administrative administrative
Personnel
Branch
Offices offices
Disposal/ Destruction
of recalled product
Completion of product Recall
Corrective Action
(Quality Assurance, Basic Cause
Summary Report (Quality Assurance, Production)
Production)
(Quality Assurance)
CPLR/ QA/024/F05-00
ANNEXURE VI
Page No. : 01 of 01
SUMMARY REPORT OF PRODUCT RECALL
1) Product:_____________________________________________ Batch No. __________________
2) Reason for Recall (nature of defect):
3) Quantity distributed:
4) Quantity of Recalled Product now on hand:
5) Feedback from consignee, depots / Distributors / Consumer:

Name
Designation
Sign.& Date

Revision No.: Nil
Review Date:
6) Action teken for returned Goods:
 Destroyed  Corrected  Under Hold
7) Corrective Action taken to prevent recurrence:
_____________________________________________________________________________
Date: _____________________
Head Quality Assurance
8) Review by Recall Committee:
Remarks:
_____________________________________________________________________________
_______________________
Sign / Date:
Copies circulated to: Marketing / Manufacturing Head / Head of Corporate Quality Assurance /
Regulatory affairs
CPLR/ QA/024/F06-00
ANNEXURE VII
Page No. : 01 of 01
LETTER TO CUSTOMER
To,
Customer Name : ___________________

Address : ____________________
____________________
Dear Customer,
This is a mock recall of the product …………………………, Batch No……………………
Kindly give us the feed back on number of units purchased by / consumed by & still remaining with you.
Name
Designation
Sign.& Date

Revision No.: Nil
Review Date:
This mock recall is just to test efficiency of our distribution network. Your response will be helpful to us
for serving you in a better way.
Thanking you, for your better co-operation
Yours truly
For:
Authorized Signatory
C & F Agency
Concept Pharmaceuticals Ltd.
CPLR/ QA/024/F07-00

Name
Designation
Sign.& Date

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CONCEPT PHARMACEUTICALS LTD.

Khasra No. 104, Asaf Nagar,Roorkee

Title: “Recall” Procedure For Marketed Product(S). SOP No.: CPLR/SOP/QA/024

Title: “Recall” Procedure For Marketed Product(S). SOP No.: CPLR/SOP/QA/024

Title: “Recall” Procedure For Marketed Product(S). SOP No.: CPLR/SOP/QA/024

 Faulty closure system.

5.11. The recall notification should include:

Prepared by Checked by Approved by

Title: “Recall” Procedure For Marketed Product(S). SOP No.: CPLR/SOP/QA/024

Recall Procedures For Overseas Countries and ANDA Products.

Title: “Recall” Procedure For Marketed Product(S). SOP No.: CPLR/SOP/QA/024

5.22. Voluntary Recall of Goods by the company.

Prepared by Checked by Approved by

Title: “Recall” Procedure For Marketed Product(S). SOP No.: CPLR/SOP/QA/024

5.23. Forced Recall of Goods.

Title: “Recall” Procedure For Marketed Product(S). SOP No.: CPLR/SOP/QA/024

Mock recall exercise (mock drill):

4. The mock recall will be done as described below :

Prepared by Checked by Approved by

Title: “Recall” Procedure For Marketed Product(S). SOP No.: CPLR/SOP/QA/024

Title: “Recall” Procedure For Marketed Product(S). SOP No.: CPLR/SOP/QA/024

Edition No. Date of Preparation / revision Reason for Revision

10. Distribution Record:

CONTROL COPY DISTRIBUTION RECORD

Prepared by Checked by Approved by

Title: “Recall” Procedure For Marketed Product(S). SOP No.: CPLR/SOP/QA/024

ISSUED TO NO. OF ISSUED BY/ RECEIVED RETRIVED RETRIVED COPY

Sub: Withdrawal of Product ……………………………, Batch No……………………

Title: “Recall” Procedure For Marketed Product(S). SOP No.: CPLR/SOP/QA/024

Signed By: ________________

Prepared by Checked by Approved by

Title: “Recall” Procedure For Marketed Product(S). SOP No.: CPLR/SOP/QA/024

To Recall Committee Ref. No. Date

From Site QA & QC

Batch No. Mfg. Date Expiry Date:

Manufacturing Location: Pack Size Batch Size Dispatched quantity

Type of Recall:  Class I  Class II  Class III  Voluntary

Reason for Product Recall:

Date: ………………… Page No. : 02 of 02

Code No. : Name:

Prepared by Checked by Approved by

Title: “Recall” Procedure For Marketed Product(S). SOP No.: CPLR/SOP/QA/024

Product: Mfg. Date

TOTAL QTY. (A)

TOTAL QTY. (C)

DESTRUCTION APPROVAL FORM

Name of the Product :

Batch no : Mfg. Dt.: Exp. Dt.:

Prepared by Checked by Approved by

Title: “Recall” Procedure For Marketed Product(S). SOP No.: CPLR/SOP/QA/024

Total Qty. Received from C&Fs : Date:

Reference for the Recall:

Reason for Recall :

Name of Challan no. Date Pack Qty.

Destruction Approved by : Director:

Destroyed in presence of : Date:

Godown In-charge: ___________________ QA Head: ___________________

Details Of Persons To Be Contacted On Urgent Basis For Products Recall

Designation : President – Global Regulatory Management

Prepared by Checked by Approved by

Godown In-charge: _ QA Head: _

1) Product:___________________________ Batch No.