SOP on Drug Product Recalls

SOP on Drug Product Recalls


To define the procedures used to effect the recall of a marketed product once it has been decided that such a course of action is required.


The  Managing  Director and  Divisional  Head shall be responsible for making the decision that a  recall is necessary, based on appropriate input from Regulatory Affairs and Quality Assurance.

The Head – Quality Assurance  (or other designated members of the Quality unit) is responsible for initiating the recall and their final disposition.

Head – Regulatory affairs are responsible for Liaison with concerned Regulatory Authority(ies).

The  Marketing and Sales Department or any business partners are responsible for providing information on the quantities and distribution of the product to be recalled.


Policy :

The company will voluntarily remove from the marketplace, as expeditiously as possible, any product that represents a potential or real threat to the safety and well-being of consumers.

The recall mechanism will be employed when evidence is received that a product has been found to be adulterated or misbranded and may present a danger to health or may be materially misleading to the consuming public.

The Concerned Regulatory Authority(ies) will be promptly notified whenever a recall is initiated, regardless of whether the recall is voluntary or initiated by Regulatory Authority(ies).

Initiating the Recall :

As soon as a  decision is made to recall a  product Head – Of Regulatory Affairs shall notify the appropriate Regulatory Authority(ies) that a recall situation may exist, and consult them about the extent of the recall, the wording of the “Recall  Letter”, and means of notification.

If the recall is a Class I (Urgent) Recall (Refer to annexure -1 for Classification of recalls): Responsibility lies with the Head – of QA or his designee.

Prepare a “Recall Letter” and submit it to the Divisional Head for comments.

Determine from Sales/Marketing the product distribution and notify all customers by phone/telegraph/e-mail that a recall exists and the extent of the recall.

 Follow up immediately with the “Recall Letter” by the most expeditious means – Air Mail or courier (return receipt requested).

Include in the Letter instructions on how the goods are to be returned, and a  request for an inventory report of the amount of product available for return.

As appropriate, include with the letter, a postage-paid self-addressed stamped envelope for the customer to use for reporting the amount of product available, and a self-addressed Label for use with the products returned.

If there is no response from the customer(s) within 7 days, vigorously follow up with phone calls/telegrams/e-mails until a reply is received.

Control of Recalled Goods: Responsibility lies with the Head -QA or his designee.

As soon as a recall is initiated, direct and oversee the quarantine of all products under the control of ***, and document the amount.

As products are returned, verify the amounts and ensure that they are placed in quarantine along with other quarantine recalls.

Actively monitor the progress of the recall and take appropriate action to ensure that the recall is effective, and response is received from all customers.

Recall Reports: Responsibility lies with Head-QA or his designee.

At monthly intervals (or as required) prepare a report for Concerned Regulatory Authority(ies) containing the following:

The number of consignees notified of the recall and the date and method of notification.

The number of consignees responding to the notification and the quantity of products on hand at the time of notification.

The number of consignees not responding.

The quantity of products returned by each consignee, and the number of products accounted for.

The number of effectiveness checks made and the results.

The estimated time frame for completion of the recall.

Send copies of the report to the Corporate Officers who need to know the progress of the recall.

The recall is ‘completed’ when the quantity of goods to be returned become minimal, which generally takes 4 months to 1 year.  After completion of recall, reconcile the product at each distributed stage.

When the recall is complete and all the product accounted for, confer with the following Officers to determine and evaluate the reason/cause for the recall and the probable impact on other products, and formulate effective actions to prevent a recurrence.

–  Divisional Head

–  Head – Production

–  Head – Regulatory

–  Head – R&D

Prepare a Final Status report for the recall and submit to Concerned Regulatory Authority(ies).

Prepare a report for the Divisional  Head which includes the conclusions and actions arrived at by the conference committee.

Class II and Class III (Non urgent) Recalls

Class II and Class III Recalls will be handled in the same manner described for Class I recalls with the following exception.

The notification of Customers by Telephone / Telegraph / e-mail is optional not required.

The recalled product shall be destroyed once the final status report is prepared and submitted to concerned  Regulatory Authority(ies)..  Record of the destruction shall be maintained.

Forms and Records (Annexures)



Master copy –  Quality Assurance

Controlled copies- Quality Assurance, Production, Quality Control,engineering





Class I is 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  is  a  situation in  which  use  of, or  exposure to, a  violative  product may cause temporary or medically reversible advserse health consequences or where the probability of seious adverse health consequences is remote.


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


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