THE EVOLVING RISK LANDSCAPE
We are proud to partner with 9/10 of the world’s leading pharmaceutical brands.
Pharmaceutical companies are faced with managing increasingly complex supply chains, heightened regulatory scrutiny and an ever-evolving risk landscape. As more independent labs, pharmacies and academic institutions take a larger role in monitoring product safety and quality, the risks to brands and reputations will increase. Companies need a clear and comprehensive plan that demonstrates their commitment to product safety and quality, strengthens quality systems to help forestall future crises, and maintains reputations with customers and market share.
Our solutions combine an industry-leading planning and implementation process with proven tools and expertise to enhance the speed and effectiveness of any product recall, market withdrawal, retrieval or in-market challenge.
Since 1995, we’ve partnered with the world’s leading pharmaceutical brands to develop, test and execute over 7,000 product recall and remediation programs across 100 countries and 50 languages.
Whether you’re planning for — or currently facing — a product recall, market withdrawal or any other in-market product incident, our experts are on hand to support you.
PHARMACEUTICAL PRODUCT RECALL
Protecting the world’s leading pharmaceutical brands since 1995.
Effective product recall management requires immediate access to pharmaceutical distribution lists in order to reach vast networks of retailers, pharmacies, medical providers and — most importantly — patients. Unfortunately, many manufacturers have gaps in their distribution networks, which can delay their recall response.
The notification, retrieval, processing, storage and disposal of recalled products are complex undertakings that require effective management of risks to minimize impacts, and safeguard patient health and brand integrity.
Sedgwick Brand Protection’s solutions provide a quality-driven processing infrastructure that includes state-of-the-art security, segregated storage of recalled product, advanced product handling equipment, and the surge capacity to assist clients in all steps of the pharmaceutical product lifecycle.
PRESCRIPTION DRUG RECALLS
Precision in prescription drug recalls: navigating safety and trust.
Despite rigorous clinical testing and stringent drug approval processes, prescription drug recalls persist. The pharmaceutical industry operates under immense scrutiny, where a single oversight can trigger class action litigation, unprecedented fines, or even imprisonment.
With pharmaceutical product recalls, there is no margin for error. This demands an unwavering commitment to precision and accountability to ensure public safety and uphold trust in the pharmaceutical supply chain.
For more than 25 years, we have expertly managed thousands of prescription drug recalls and market withdrawals, and expertly mastered complex and evolving regulatory guidelines. Today we are proud to partner with 9 out of the world’s leading 10 pharmaceutical brands – discover how we can support you.
OVER THE COUNTER DRUG RECALLS
Navigating complex consumer notification and removal challenges.
Over-the-counter drug manufacturers and retailers encounter the challenging responsibility of notifying consumers during a product recall. The extensive distribution and widespread use of these drugs add layers of complexity in the logistics of their retrieval. Since 1995 we have supported drug manufacturers and retailers in removing affected products from shelves and consumers’ homes with the speed and accuracy demanded by regulatory agencies.
Our product recall experts specialize in addressing operational hurdles, delivering essential drug recall services such as on-site product effectiveness checks, notification services, product processing, secure storage facilities, and mandated preparedness planning. Discover how we can support you.
For over a decade, Sedgwick brand protection has published its quarterly Recall Index report. Downloaded in more than 100 countries, the Index has established itself as the definitive guide to pharmaceutical product safety. Access high-level insights below and download our latest edition in full.
U.S. PHARMACEUTICAL PRODUCT SAFETY & RECALL INSIGHTS
Quarter 3, 2023
The number of pharmaceutical recalls in Q3 2023 dropped by 20.7% from Q2 2023 to 107 events. The number of units recalled decreased even more, going from 24.24 million units in Q2 to 7.42 million in Q3, representing a decline of 69.4%. Sterility was the leading cause of pharmaceutical recalls with 45 events, or 42.1% of total recalls. Sterility also had the most units recalled in Q3, with 4.10 million, or 55.2% of recalled units. There was only one recall in Q3 that impacted more than 1.00 million units.
Failed specifications were the second-most common cause for pharmaceutical recalls in Q3 2023, linked to 16 events. This concern was also tied to the second-highest number of units recalled with 1.50 million. cGMP deviations were third in terms of events with 13 recalls.
Both the number of recalls and the units impacted rose for Class I recalls. While the number of events only increased from seven to eight, the number of units impacted grew from 21,099 in Q2 to 692,869 in Q3. The number of recalls and units for Classes II and III were lower, with Class II units falling from 23.09 million in Q2 to 6.28 million in Q3.
Quarter 2, 2023
The number of pharmaceutical product recalls fell 6.3% from 144 in Q1 2023 to 135 in Q2 2023. This does not include any of the 85 voluntary recalls issued by a manufacturer that filed Chapter 7 bankruptcy in February 2023. The FDA has yet to report any unit numbers for these recall events.
There were 24.2 million pharmaceutical units recalled in Q2 2023, a 51.1% decrease from last quarter. The average product recall size also fell to 179,587 in Q2 2023. That is the second-lowest total since Q1 2019.
Sterility was the leading cause of pharmaceutical product recalls with 54 events, or 40.0% of total activity. Sterility also accounted for the most units recalled in Q2, with 18.7 million, or 76.9%. cGMP deviations were the second-most common cause for pharmaceutical recalls with 24 events.
Quarter 1, 2023
Q1 2023 recorded the highest number of pharmaceutical product recalls in a single quarter in the past 18 years. There were 144 recall events, an increase of 53.2% compared to last quarter. The number of units recalled rose even more dramatically, from 4.2 million to 49.5 million units.
cGMP deviations were the leading cause of pharmaceutical product recalls with 70 events (48.6%). This is the highest number of recalls for cGMP deviations in a single quarter in over five years. cGMP deviations also had the most units recalled in Q1, with 33.2 million.
Failed specifications were the second most common cause for both product recall events and units impacted with 23 events involving 9.64 million units.
EUROPEAN PHARMACEUTICAL PRODUCT SAFETY & RECALL INSIGHTS
Quarter 3, 2023
Pharmaceutical recalls across the EU and UK increased by 48.6% in Q3 2023 compared to Q2 2023. There were 110 events this quarter compared to 74 in the previous quarter.
Safety risks was the leading cause of pharmaceutical recalls and was linked to 22 events this quarter, down slightly from 30 events in Q2 2023. The second-most common concern was foreign materials/contamination with 19 events, followed by mislabelling with 15 events in Q3. Last quarter, only eight recalls were attributed to foreign materials/contamination, and five were tied to mislabelling.
Germany had the most notifications, issuing 22 alerts in Q3 2023, up from 10 last quarter. France was second with 20 notifications and the UK was third with 19. Portugal followed with 15 notifications in Q3.
Quarter 2, 2023
Pharmaceutical product recalls across the EU and UK dropped by 14.0% from 86 in Q1 2023 to 74 events in Q2 2023. Despite this decline, at the halfway point of 2023, European pharmaceutical product recall activity is up 8.8% from 147 in H1 2022 to 160 events in H1 2023.
Accounting for 30 events, safety risks were the leading cause of pharmaceutical product recalls in Q2 2023. The second-most common concern was quality with nine events, followed by foreign materials / contamination with eight. France was responsible for the most recall notifications, issuing 19 in Q2 2023, followed by Spain and Germany with 10 each, and then the UK with eight.
Quarter 1, 2023
European pharmaceutical product recalls declined 17.3% in Q1 2023 compared to Q4 2022. There were 86 events compared to 104 the previous quarter. It is worth noting that Q4 was very active with a much higher number of product recalls than the rest of the year.
Safety risks were the leading cause of pharmaceutical recalls, linked to 31 events this quarter. The second-most common concern was foreign materials / contamination with 12 events. In third was mislabelling with 11 product recall events.
France issued the most recall notifications, with 23 or 26.7% of the total figure. The UK followed with 16 notifications, up from 13 in Q4 2022. Germany had 13 notifications (down from 17 in Q4), which put it in third place.
Streamlining returns processes for the pharmaceutical sector.
To effectively manage product returns, pharmaceutical companies need streamlined processes and a proven infrastructure. Our fully automated, in-house tracking and monitoring services simplify the returns process to effectively handle expired and nonperforming inventory, reduce human error, and increase processing efficiencies.
With fast returns processing and a focus on accurately applying each manufacturer’s specific return policy, Sedgwick’s brand protection solutions efficiently generate the data necessary for reimbursement.
Leveraging three decades of industry experience and expertise, our proven best practice strategies and executional proficiency provide comprehensive support to drug manufacturers
INDUSTRY-LEADING CALL CENTER SOLUTIONS
With Sedgwick Brand Protection, gain 24-7-365 access to a global team of brand ambassadors ready to field calls from concerned customers.
Our expertise extends beyond the handling and resolution of product recall inquiries, to encompass a wide range of business and drug related challenges – from market withdrawals, product safety alerts, corrective action programs, and much more. Since 1995 we have provided the pharmaceutical industry with:
- Instant on-demand support that adds flexibility and agility to existing customer engagement infrastructures, alleviating pressure on resources as call volumes surge – ensuring vital day-to-day business operations are not compromised.
- Scalability in size and duration, from short-term engagements to long-term programs in response to one-time product recalls or persistent issues. Flexibility on-demand – simply dial up and down as required.
How a potential benzene contamination led to a 4M+ unit recall of a ‘high-demand’ product.
Recalling 10M+ hand sanitizer products amid a pandemic-driven national lockdown.
Download our Recall Index
Essential insight and analysis for mitigating pharmaceutical product recall risk.
SEDGWICK BRAND PROTECTION
The world's leading product recall company
For over 25 years, companies of all sizes and sectors have trusted our expertise in preparing for and managing their product-related challenges. Since 1995, we’ve successfully managed more than 7,000 of the most sensitive and time-critical product recall programs, spanning 100 countries and 50 languages.
Whether your in-house teams need scalability to maintain daily operations during a product crisis, or you require a complete end-to-end product recall solution, we have the experience to protect your brand and peace of mind.
If you’re currently facing a product recall, or seeking to enhance your recall readiness, contact us now.
Whether you’re planning for — or currently facing — a product recall, market withdrawal, or any other in-market product incident, our experts are on hand to support you.