By Dhansukh Viradiya
Definition:
➡️ Action taken by a firm/facilities for removal and or correction of a marketed product that is in violation of applicable laws and may pose potential hazard to public health and/or for which there are established deficiencies in quality, safety and efficacy.Preamble:
➡️ A drug recall is the most effective way to protect the public from a defective or potentially harmful product. A recall is a voluntary action taken by a company or by USFDA request at any time to remove a defective drug product from the market.
➡️Even though a company's best efforts to design, manufacture, packaging and sell safe and reliable products, the probability still exists that dangerously defective products may reach the customers. These products may cause accidents, leading to adverse outcomes in product liability litigations. There for quality management of complaints and product recalls are essential to ensure the safety of customer.
➡️Market Complaints and product recall are inter related. We don’t discuss in details of market complaints in this article.
➡️ I will be prepared another article about market complaints. ➡️ Any confirmed/substantiated market complaint for quality/efficacy/safety issue will necessitate drug product recall.
➡️ I will be prepared another article about market complaints. ➡️ Any confirmed/substantiated market complaint for quality/efficacy/safety issue will necessitate drug product recall.
Purpose of Recall:
➡️ The purpose of the drug recall is to ensure that the drug is effectively and rapidly withdrawn from the market.Reasons for a Product Recall:
A product recall might be:
➡️ Instructed by a regulatory agency due to violation of a government act, it’s standard or other mandatory regulations.
➡️Required to avoid potentially serious additional product liability claims or losses.
➡️In case of product tampering, near miss incidents, accidents or consumer complaints.
➡️Suggested by new information based on additional research and product testing.
➡️ Needed when characteristics of the product don't measure up to the advertised claims for safety or effectiveness.
➡️Against evidence or possibility of extraneous matter/chemical contamination/ microbiological contamination.
➡️Physical and visual deterioration of product, such as significant discoloration, sedimentation, lump formation, crystallization, leakages, etc.
➡️Any critical noncompliance identified after post-dispatch of batch.
USFDA’s Role:
➡️ To oversee a company’s strategy, assess the adequacy of the recall and classify the recall.Recall Classification as per USFDA:
1) Class I:
➡️ A dangerous or defective product that could cause serious health problems or death.
2) Class II:
➡️ A product that might cause a temporary health problem, or pose slight threat of a serious nature.
3) Class III:
➡️ A product that is unlikely to cause any adverse health reaction, but that violates FDA labeling or manufacturing laws.
Notifying the Consumer:
➡️ Company circulate recall instructions using FDA official site, telephone, telegram, postage, mass media, radio TV, depending upon the seriousness of the defect.
➡️ Not all recalls are announced on FDA.gov or in the news media. Public notification is generally issued when a product that has been widely distributed or poses a serious health hazard is recalled. However, if a company does not issue public notification of a recall, FDA may do so if the agency determines it is necessary to protect patients. Patients also may learn that their medicine has been recalled through notification from the manufacturer, their health care professional or pharmacist.
➡️ If you have a medicine that has been recalled, talk to your health care professional about the best course of action for your health, including the possibility of returning the product to the store in which you purchased it.
➡️ Stores generally have a return and refund policy when a company has announced a recall of its products. Generally, Class I recall notifications provide instructions with actions for patients. FDA recommends that patients follow the instructions provided by the recalling company.
FDA enforcement report:
➡️ All recalls are posted weekly in the FDA enforcement report. Current recalls that have not been classified are also published in the enforcement report as “not yet classified” in the classification field. After finalization of recall class, it should be updated in enforcement report with its relevant classification.
Recall committee:
➡️ It must be prepared site recalls committee including site QA head, regional QA head, QC head, RA, Engineering, Pharmacovigilance etc. for handling of recall activity.Product recall proposal:
➡️ It shall be initiated by the recall initiator with the following information (but not limited to):- Product/generic name
- Market
- Batch no
- Material code
- Manufacturing date
- Expires date
- Country product code
- Recall source
- Reason for recall
- Class of recall
- Depth of recall
- Risk category etc.
➡️ Field alert report must be submitted to FDA within 3 days by applicant, after receiving information of significant quality problem from distributed drug product.
Determining the Effectiveness of the Recall:
➡️ FDA evaluate the effectiveness of a recall by evaluating a company’s efforts to properly notify customers and remove the defective product from the market. If a recall is determined to be ineffective FDA will request the company take additional actions.
➡️ The firm recall committee shall finalize the level of effectiveness checks as follows:
Level A- 100% of the total number of consignee will be contacted in life threatening situations
Level B- 10 to 100% of the total number of consignee will be contacted in potential hazard situations
Level C- 10% of the total number of consignee will be contacted
Level D- 2% of the total number of consignee will be contacted
Level E- Effectiveness check not required in no serious hazard situation.
Closure of product recall:
➡️ Recall activity may be consider complete and closed after final reconciliation report or recall summary report has been approved by recall committee members.Mock recall:
➡️ Mock recall has been conducted by facilities to challenge its recall process. It should be done in once annually, if no recall happened during this period.
➡️ Go through below guidelines for more information.
1. US FDA 21 CFR Part 7 Subpart C-Recalls, Part 314.80, Part 806.
2. Indian guideline: Guideline on recall and rapid alert system for drugs (including biological & vaccines).
3. EudraLex volume 4, capter 8: Complaints, Quality defect and product recalls.
4. PIC/S Procedure for handling rapid alerts and recalls arising from quality defects (PI 010-5) July 2017.
About the Author:
Dhansukh Viradiya is a highly accomplished expert in the pharmaceutical and biopharmaceutical industries. With over 10 years of experience in the field, he has gained comprehensive knowledge and expertise in various areas, including Process Validation, Cleaning Validation, Quality Management System, In-process quality assurance, Qualification etc.
Mr. Dhansukh holds a Master's degree in Pharmacy from a renowned University, where he specialized in Quality Assurance.
As a thought leader, Mr. Dhansukh has published numerous articles and white papers on various topics related to pharmaceutical and biopharmaceutical industries. His research work focuses on emerging trends, current regulatory expectations, advancements in technology, personalized medicine, and the intersection of healthcare and technology.
With his passion for improving patient care and dedication to advancing the field, Dhansukh Viradiya continues to make significant contributions to the pharmaceutical and biopharmaceutical industries. His insights and expertise make him a valuable resource in understanding the dynamic landscape of these sectors and their impact on global healthcare.
Disclaimer:
The author's biography is provided for informational purposes only and does not imply any endorsement or affiliation with the article or its content.
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