1.0 Introduction
Recall is the process where a product is removed from the supply chain or distribution due to defects in product or adverse effects or complaints initiated by consumers or health department
1.1 Stages in Product recall
A product recall involves the following steps
1.1.1) Initiation of recall
Recall initiated by the licensee should be accompanied by recall notification form.
This should be informed to the senior pharmacist and early notification (licensee shouldn’t wait till all applicable information is assembled) should be given by the licensee which helps in reviewing and assisting the recall process
i) The following details of the problem should be furnished
Contact details of the person who is reporting like name, telephone number and facsimile number
Report date
Location where the problem occurred
Number of the same report received
Test results and investigation reports
ii) The following details of the product should be furnished
Product name & description – API, dosage form, strength, pack size or pack type, registration number
Batch number and quantity of batch
Manufacture & expiry date
Amount manufactured
Manufactures name and address and contact numbers
iii) Evaluation and action initiated for health hazard
Hazard type and evaluation of the health hazard with regard to user
Action initiated by licensee
Recall classification and level
Alternative product availability
1.1.2) Assessment of recall
Before classifying recalls the following should be considered for formulating recall strategy
Extent of recall and its impact in distribution chain
For recall at wholesale level proper reason should be given regarding their recall
For recall at consumer level information on recall spot locations, time, duration and also refund mechanism should be notified
Communication method like phone, mail or facsimile should be mentioned
Method of delivery of message to customers like letters or press release
Posting the recall notification on website if the licensee has a website
Instructions given to the customer
Name and address of the recall contact person
In case of returning products, process involved should be detailed
Action to be initiated by out of business distributors
If the product needs to be destroyed then inform the department of health before destroying
i) Recall Classification
Class I - When products are life threatening and pose threat to health then class I recall occur
Example - Wrong labels and product strength, contamination and mix up, wrong active ingredient
Class II- When defective product causes illness or improper treatments then class II occurs
Example - Improper labels, improper product strength, contamination and mix up, noncompliance with specifications
Class III - When defective products doesn’t indicate a health hazard but is withdrawn due to other reasons then class III recalls occur
Examples – Faulty packaging or closure, contamination
ii) Levels of recall
Wholesale level
Retail level
Consumer level
1.1.3) Communication of recall
Recalls can be communicated to the public either by press releases or by recall letters
1.1.4) Refund mechanism
Refund mechanism procedure should be given by licensee
1.1.5) Report
Final report should be given to health department with the given information
Circumstances leading to recall and actions initiated by the licensee, Impact of recall, method of refund and destruction of the products
1.1.6) Evaluation of recall
Licensee should assure that the recall is evaluated with proper investigation of root causes and remedial actions taken
Product recall procedure, licensee, levels of recall , recall classification
