Product recall is a method of removal or correction of marketed product of a industry that does not comply to the laws as per Food and Drug Administration (FDA) which would be subjected to legal action. It does not involve products that are under stock recovery or are in market withdrawal products that are under minor violations of laws.
Certain misleadings can lead to product recall but it should be reported as fast as possible and the distribution chain helps a lot in this process. Based on the severity of the recalls of product which is decided by the HEALTH HAZARD EVALUATION done by the ad hoc committee of FDA , they are classified by FDA as follows:
The another classification based on initiation of recall is as follows:
Most of the recalls are voluntary because the manufacturer and distributors understand their important role towards the public health and mankind and are completely aware of the consequences associated with the violated products.
The recall strategy considers following factors to develop the basis of FDA requested product recall that is initiated by the recalling firm:
- The results of the health hazard evaluation.
- Ease in identifying the product: This is done by evaluating the supply chain and records. This factor is selected if all the products distributed are easily traceable.
- Degree of deficiency of product and it’s effect on the consumers is obvious.
- Degree to which the product remain unused in the market.
- Continuity in availability of the essential products.
The recall strategy based on the justified factors must be sent to FDA for approval and must be conducted as per FDA (if any amendments done). The initiation of recall must be done as soon as the violated product is identified and then conduct as per approved recall strategy.
DEPTH OF RECALL:
The extent to which the violated product is distributed in the distribution chain is identified. The levels are set to define the depth of the recall:
- Consumer Level
- Retail Level
- Wholesale Level
Note : Any intermediate levels between wholesale to retail will be included in retail level and any intermediate level till consumer level (wholesale and retail intermediate) will be included in consumer level.
This is an extreme step as the recalling firm will generate public warning against its product in front of the public hence it is only done when all the other means are inadequate in recalling of the violated product. Once a recalling firm decides to generate public warning it should submit the draft of the proposed means of public warning distribution plan to FDA for review and comments. It will be reviewed on the basis that whether there is need of the public warning, if yes, then by general public warning (General news media) or by specialised alerts (including the professionals, also hospitals and centres).
This is done by the recalling firm with assistance of FDA wherever required. The effectiveness check made the basis that the consignees as per recall strategy chain are informed about the violated product and they have taken appropriate actions according to the recall strategy. The consignees may be contacted by any means: personal visits, phone calls or both. There are certain levels of effectiveness checks developed as per FDA: