WHAT IS PRODUCT RECALL:

Removal or correction of marketed products for the reasons relating to deficiencies in quality, safety or efficacy, including labeling considered to be in violation of the laws.

 PROCEDURE:

Any batch of a product not meeting the defined quality standards has to be recalled from the market. Recall can be of two types; Voluntary Recall and Statutory Recall.

Voluntary Recall: Voluntary recall can be triggered by any incident that affects the quality, safety and efficacy of the batch/product in question such as

 ·If the batch or batches are found to be not complying with the regulatory specifications during the post marketing stability study

 ·If the batch is found to be defective during investigation of market complaint.

 ·During any failure investigation, if it is observed that the failure under investigation might have adverse quality impact on already released batch.

 ·If any unusual observation is noted during visual inspection of reserve samples which indicate an impact on quality of the product after investigation.

 ·If the post marketing surveillance reports /pharmacovigilance reports indicates that there is serious safety risk associated with the product.

 Statutory Recall: Statutory recall can be triggered in response to the direction or mandate by the Drug Regulatory Authorities.

 ·To recall the drug product/batch, considered to be in violation of the laws, it administers such as not of standard quality etc.

·To recall the banned drugs.

·Labeling and / or Promotional materials that are considered to be in violation of law.

Recall Logging: Once a potential product recall situation is identified Head-QA/designee shall enter the details in Product Recall log

Designated QA person shall assign a product recall number to the same

In case of product recall, Head-QA or his designee shall intimate to the members of Recall Co- ordination Committee (RCC) and organize for a meeting.

The RCC members shall evaluate the known information on the nature and extent of the health risk taking inputs from Head-Medical department

 Based on the evaluation, the RCC members shall classify the recall as Class I, Class II and Class III to indicate the relative degree of health hazard of the product being recalled or considered for recall.

Class I Recall:

These are recalls which result from quality defects of medicinal products which are potentially life threatening or could cause serious risk to health.

Class II Recall:

These are recalls due to quality defects which may cause mistreatment or harm to the patient but it is not life threatening or serious.

Class III Recall:

These are recalls due to quality defects which are unlikely to cause harm to the patient, and the pose a significant hazard to health but where a recall has been initiated for other reasons, such as non- compliance with the marketing authorization or specification.

Levels of Recall:

The level (or depth) of recall of a product/batch shall be determined based on recall classification and level to which distribution has been taken place.

There are three levels of recall such as consumer /user, retail and wholesale.

Consumer or User Level: This may vary with product, including any intermediate wholesale or retail level. Consumer or user may include individual consumers, patients, physicians and hospitals.

Retail Level: Recall to the level immediately preceding consumer or user level. It includes retail shops, pharmacies, hospital pharmacies, dispensing physician, institutions such as clinics and nursing homes, etc.

Wholesale Level: All distribution levels between the manufacturer and retailer.

Class I Recall: Notification and acknowledgement of receipt of recall notification within 24hrs.

Class II Recalls: Notification and acknowledgement of receipt of recall notification within 48 hours.

Class III Recalls: Notification and acknowledgement of receipt of recall notification within 5 days.

Mock recall shall be done to evaluate the effectiveness of arrangements periodically to recall the products from EU / US / Australia / other export markets and domestic markets. Mock recall is applicable only to markets where product is already marketed.

Frequency of Mock Recall shall be once in two years or as per MA Holder / Contract giver requirement.