Product recalls are a process that all companies are trying to prevent, but need to be planned and implemented efficiently when needed, without delay or confusion.
When in the process of recall, subjects that need to be taken into consideration can be divided into seven groups.* These areas must be taken into account in order to carry out the recall process efficiently. These seven topics are:
Simply, recalling is the only way to ensure the safety of a user when a product is found to be faulty for any reason. Recall may be voluntarily requested by the manufacturer or distributor, or may be requested by the authorities in case of emergency and necessity.
After the health-hazard analysis is performed, how the user is affected and its results will have to be reported. Once the report is reviewed, solution to the said problems will be determined. After planing the solution all relevant departments should be contacted about it.
The plan should include the information of the drug to be collected, how the error occurred and the effects of the error, the amount of drug to be collected, the amount of wrong drug delivered and the direct users.
The level of recall is determined according to the information on the plan made and the results of the health-hazard analysis. The recall process can be at the manufacturer level, the pharmacy level or the user level.
Recall at the user level is the most serious type of recall and points out that there is a life-threatening use of the faulty medicine. Therefore, the plan should be executed post-haste and with cautious.
Before the plan is executed, it is absolutely necessary to inform the authorized people and send an announcement from the relevant channels. Recall processing systems, which may vary according to different countries, generally operate with the same logic. The records of the recall process reported to the authorities are kept to cover every faulty drugs. If the patient already used the faulty drugs, the necessary treatment should be provided.
Recall cannot be completed without the approval of the authorities. This means that even if all of the faulty drugs are seized and the safety of the patients is ensured, the procedure will be completed with a cancellation letter given by the relevant authorities.**
** FDA, Guidance for Industry: Product Recalls