Drug Recall

 A process of pharmaceutical product withdrawing or removing from the pharmaceutical distribution chain because of defects in the product, complaints of serious adverse reactions to the product . 

The manufacturer, wholesale dealer licence holder, or Department of Health can initiate the recall of drug.

NOTIFICATION OF A PHARMACEUTICAL PRODUCT PROBLEM 

 By reporting or complaints on quality, safety or efficacy on a pharmaceutical product recall is initiated and referred to the Licensee from a variety of sources .The reports or complaints may be referred by manufacturers, wholesalers, retailers and hospital pharmacies, research institutes, medical practitioners, dentists and patients. Recall might also be initiated as a result of analysis and testing of samples of products by the manufacturers and by the Dept of Health.

INFORMATION REQUIRED FOR ASSESSMENT OF RECALL

Details of the Problem :Name, telephone  number of the person , date of report  of problem.

Product details:  Name of the product and description including active ingredients.     

            Dosage strength, registration no, pack size , type, batch number(s) and expiry date .  

            Date and amount manufactured and imported

            Local distribution list. 

   Health hazard evaluation and proposed action: 

          Type of hazard, and evaluation, action proposed by the Licensee.

1.Classification of  Recall of Drugs   

Class I recalls : when products are potentially life-threatening or could cause a serious risk to health.    

 Examples :

 label and contents are different products, wrong product,  Correct product but wrong strength .

Microbial  and Chemical contamination . 

Class II recalls:  when product defects could cause illness or mistreatment, but are not Class I.

 Examples of Class II Defects –

 Mislabeling wrong or missing text or figures 

  Incorrect information- leaflets or inserts 

 Microbial contamination,  Chemical/ physical contamination  .

Class III recalls:  If product defects may not have a significant hazard to health, but withdraw may be initiated for other reasons.

 Examples of Class III Defects – 

Faulty packaging  missing batch number or expiry date , Faulty closure .

 Urgent safety-related recalls are considered in class I and class II. They must be reported to the Department of Health for further evaluation and investigation. 

 Non safety-related recalls are considered in class III.

2. Classification of Recall  based on level of distribution assigned by dept of health.

There are 3 levels of recall: 

WHOLESALE  LEVEL : -  wholesale distribution - may include wholesalers and retail pharmacies.

RETAIL LEVEL : - All public and private hospital pharmacies, Retail pharmacies ,Medical, dental and other health care practitioners, Nursing homes ,  medicine shops, health food stores.

CONSUMER LEVEL : - Patients and other consumers .

COMMUNICATION TO PUBLIC 

Recall letters , the Licensee may prepare letters with a  statement of the reasons for the recall of the product, together with specific details that will allow the product to be easily identified. 

The letter may be sent by mail,  e-mail to the clients.

The recall letter should use company letterhead, include date and name and title of signature. The text of recall letter may include:

a. Description of the pharmaceutical product.

b. name of manufacturer, pack size; dosage form; batch number(s) and expiry date,

c. Hazard associated with product .

PRESS RELEASE

  Rapid alert to public may be issued through channels which may include press release.

RESPONSIBILITIES OF LICENSEES 

Licensee has responsibilities in relation to recall of products in two general areas: 

a. In maintaining records and establishing procedures which will assist in recall

b. They prime responsibility for implementing recall 

RECALL PROCEDURE

  Licensee and senior personel should prepare procedures for recall action which comply with the Guidelines and which are applicable to their own operations of products.

PROBLEM REPORTING 

Where recall may be necessary  the report must be conveyed with the least possible delay to the Dept of Health, including  products that have been exported.

Recall Licensee has the prime responsibility for implementing recall action, and for ensuring compliance with the recall procedure at its various stages .

A responsible officer for recall should be appointed to coordinate the recall and his/her name and contact phone number should be notified to Dept of Health.  

 Licensee should notify its clients within 24 hours upon the decision of recall in class I recall.

POST-RECALL

 After the timeframe directed by Dept of Health to complete the recall,  the Licensee is to provide interim report during recall process  within 7 days after initiation of recall.

 A final report  should be submitted to Dept of Health within 14 days after commencing of the recall.

COMMENCING OF THE RECALL:

After completion of the recall, a report  investigation results on the problem and the action  to be implemented in future to prevent  recurrence of the problem should be submitted to Dept of Health .

These reports establish the effectiveness of the recall and unless  satisfactory  reports are received, further recall action may have to be considered.

 when a drug is recalled: 

• Get educated.  visit the FDA web site. You can sign up to receive alerts on  recalls and market withdrawals. If you notice  unusual with a medication or medicine bottle or wrapper, odd smelling, contamination, notify your pharmacist before taking it, regardless of whether the drug has been recalled.

• Safely discard recalled drugs. Even if you  currently taking the medication, check your medicine c for the recalled product and, should  discard it safely or return it to the pharmacy. Most drugs can  safely disposed  in trash after mixing it with a substance like coffee grounds  and then sealing it in a container or plastic bag. If you have kids in the house, make sure you dispose of the medicine in a way that they cannot get to it. Only in rare circumstances should medicine be flushed down the toilet. See instructions for disposal on the medicine’s label .

• Call your doctor.  call your doctor immediately if you have taken a drug that has been recalled and have any unusual symptoms.

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                                                                                                                DR.SUJATHA .M

                                                                                           REF ID:CSRPL_INT_WKD_HYD_0061/20