MARCH 2022
Matthew Lippman, HUB International
A recent FDA alert urged all companies to be “recall ready” to ensure appropriate, swift action across distribution channels and protect public health and supply chain integrity when the agency calls for the voluntary removal of products from the market.
FDA’s newly-released guidance describes steps companies should take—before a recall is necessary—to develop recall policies and procedures that include training, planning, and record-keeping.
The guidance details key recommendations that companies:
- Identify appropriate personnel and make sure they’re trained on their responsibilities
- Establish a recall communications plan
- Identify reporting requirements for distributed products, using adequate product coding
- Maintain distribution records
Company preparedness limits the public’s exposure to risk. For recalling firms, having specific procedures for initiating a recall and performing actions related to initiating a recall may help reduce the amount of time a violative product is on the market.
A voluntary recall is an action taken by a company to correct a violative product or remove it from the market. A recalling company may act on its own initiative, or the FDA may inform the company that a distributed product violates the law and recommend the company recall the product.
Having a Product Recall policy with the features and endorsements necessary to protect your business is vital to staying ahead of the competition. As the pace of innovation increases, so does the importance of working with an insurance broker who understands the complexity of your business and can provide coverage to keep you protected in the event of a recall.
Leading full-service insurance brokerage HUB International offers a stand-alone Product Recall insurance product for the Life Sciences industry to cover costs such as customer notification, shipping costs, disposal costs and much more.
POLICY STRUCTURE:
- Claims made with cutoff date Recall Liability and Recall Expense;
- Policy Limits up to $2M available on primary basis;
- Deductible and participation percentage options available.
AVAILABLE COVERAGE ENHANCEMENTS:
- Optional Additional Coverage - Loss of Income due to Loss of Reputation with Optional Extra Brand Remediation Expenses;
- Optional Cyber Security Consultant Costs
- Endorsement for “smart” products and digitally connected medical devices;
- Optional Fair Trade Recall Trigger Endorsement;
- Optional Pre-Recall Monitoring Expenses Endorsement;
- Optional Surgical Removal Costs Endorsement for implantable medical devices;
- Self-initiated recall and government-initiated recall triggers.
Work with the experts at HUB International to learn how you can protect your business and set up your product recall plan today.
Matthew Lippman currently serves as a Vice President and Life Sciences Practice Leader with HUB International Northeast, a leading full-service insurance brokerage. Matthew holds nearly three decades of experience with providing individuals and businesses with customized, comprehensive insurance and risk management solutions, specializing in the Life Sciences industry, specifically pharmaceutical and nutraceutical companies. He can be reached at 516-396-8211 or matthew.lippman@hubinternational.com.
