Product Recall Procedure in Pharmaceuticals : Pharmaguideline

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Product Recall Procedure in Pharmaceuticals

Learn how the marketed pharmaceutical product is recalled from Domestic and Foreign market.


A recall is defined as the Company's removal of a marketed product because of design or production defects that may compromise safety, efficacy and purity of the product or because of government regulation.
A recall of a marketed product will be instituted when either the product is suspected or proven to be defective based on stability study, market complaints, assessment of likelihood occurrence of the hazard or if directed by the Food and Drugs Administration or any Drug Control Authority or health / regulatory authorities (RA) of the country where the product is marketed.

The recalled stock shall be stored separately and securely till the decision on further action by recall committee is finalized.
Forms as per Annexure - 2 in which replies are requested to be obtained from distributors, stockiest. etc., regarding confirmation that they have returned the products should be made available to each member of the field in enough quantity. After the batch is returned to the company, it will be destroyed in a manner that may be decided by the committee.
The progress of recall is monitored and closed by Head – QA & QC on information of product withdrawal details. The details are recorded in Annexure – 3.
The returned stock statement shall be submitted FDA.
After completion of all regulatory requirements, the stock of returned material shall be destroyed by appropriate method.

Recall status report

The company will submit periodic recall status to the FDA. The frequency of these reports will be specified by FDA. These reports should contain the following information:
Number of consignees notified by the recall, and the date and method of notification.
Number of consignees responding and quality of product on hand at the time recall communication received.
Number of non-responding consignees.
Number of products returned or corrected by each consignee contacted and accounted for.
Number and results of effectiveness checks made.
Estimation as to recall completion time.

Recall procedure for foreign countries

The overseas agent / contract giver, where the product has been shipped shall be immediately intimated about the nature of defect in the product and its likely hazards with respect to general health by fax, mail and telephone. The overseas agent / contract giver shall initiate the recall in the respective country or as specified in the agreement / contract.
As the fail-safe policy, the dealer and or agent shall be instructed to intimate the wholesalers and retailers, where he has distributed the product about stoppage of use and return back all the stock back to him All the requirements of countries regulatory authority shall be completed jointly by company as a manufacturer and contract giver or principal company as a distributor or license holder.
After recalling the stock back to dealer, the arrangement shall be made to ship the recalled stock back to India or destroyed in the country where exported.
When FDA / regulatory authorities terminates the recall, recall reports are to be discontinued.
The progress of recall shall be recorded and the final report be issued including reconciliation between the delivered and recalled quality to the regulatory authorities of the country from where the product is recalled.



SUBJECT: Recall of Product.
Generic Name        : _____________________________________________________
Brand Name          : _____________________________________________________
Pack Size               : _____________________________________________________
Batch No.              : _____________________________________________________
Mfg. Date              : _____________________________________________________
Exp. Date               : _____________________________________________________
Nature of Defect    : _____________________________________________________
Health Risk            : _____________________________________________________
Time Frame           : _____________________________________________________
Dear Sir,
We had supplied the above mentioned product vide our challan / Invoice No. :         , Date :_______. You are hereby advised to return whatever stocks available with you to our factory godown situated at ________________.
You are also advised to call back all the stocks sold to the dealers to whom you have sold. On completion of the process of withdrawal, you are requested to intimate to us total stocks thus withdrawn and return it back to us for further action. Please inform us accordingly in the format attached (Annexure 2).
Do not distribute / sale the product.
Thanking you.

Yours Faithfully,

(Head QA&QC)
This is to confirm that we have received your instruction for the recall of the product(s) mentioned below.

Sr. No.
Name of the Product
Dosage Form
Pack Size
Batch No.
Mfg. Dt.
Tick what is applicable.
We confirm having returned to your                          warehouse                        units of the above product,
We confirm we have no stocks of the above products.
Signature with Rubber Stamp of Customer
Filled copy to be forwarded to Head QA & QC

Name of the Product : _________________________  Pack / Strength : ____________________
B. No.
Sr. No.
Received From
Quantity Distributed
Quantity Received
Total Qty. Received
% Received
QA Remarks :

The recall is closed.

       Head – QA & QC

Product recall committee
Product recall committee consist of following members
a)  Director Technical
b)  Vice President - Technical
c)  Head - Regulatory
d)  Head- Production
e)  Head -QA & QC
f)  Head – Marketing

Type of product recall

Class I :

This is for dangerous or defective products that cause serious consequences to health including death.  The decision to make an urgent recall will be taken by the committee on the advice of the medical adviser. The recall is initiated within 3 working days from received date.

Class II :

Such recalls are executed for products, which are found to be defective or substandard, but which do not pose a health risk or might cause a temporary health problem. The recall is initiated within 7 working days from received date.

Class III :

These are recalls for products that are unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing regulations.
In case of product manufactured for Contract Giver or Principal Company, the information should be communicated by Head QA&QC to authorised person of contract giver or principal company as specified in technical agreement.
All the recalls shall be communicated to the regulatory authorities of countries from where the product recall is scheduled.

Recall procedure

Head QA & QC will investigate the market complaints, stability failure to evaluate the risk associated and initiate product recall.
In case of directives from regulatory authorities, the product recall will be commenced as per the directives.
Head – QA & QC will decide the type of recall in consultation with recall committee.
Head – QA & QC will communicate the decision of product recall with product details to Director – Operations / Distribution Manager / Contract Giver / Principal company, as the case may be for effecting recall and to Chief Executive Officer for information.

Recall procedure for domestic market

Director Operation / Distribution Manager will send a product recall circular with time frame, immediately to various concerned persons in distribution to return all the stocks of product and informing them that credit note for the stocks returned will be issued to them at the earliest. He will also instruct to stop further sales of the product of the said batch at every distribution / sales point. They will have to be requested to reply to the company. However, in case of urgent recalls in addition to sending circulars immediate contact with concerned persons should be established by telephone, fax, email or any other available means.
All product recall must be executed expeditiously. 

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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2 comments: Post Yours! Read Comment Policy ▼

  1. Mock recall shall be performed once in 2 years in order to check effectiveness of the recall procedure.

  2. What are the criteria for a recall to be successful? e.g. Percentage of product removed from the market...


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