In 2020, the Food and Drug Administration announced several large-scale medical device and drug recalls and two high-profile market withdrawals.
Overall, there were more recalls for medical devices and pharmaceuticals in 2020 than there were in 2019. Several litigations involving drugs and medical devices saw spikes in new cases in 2020, some fueled by recalls.
We’ve compiled a list of some of the year’s most notable recalls and market withdrawals.
1. Zantac and Metformin
Recalls stemming from contamination with a toxic carcinogen called N-nitrosodimethylamine (NDMA) ramped up in 2020. The main drugs affected by NDMA recalls in 2020 were Zantac (ranitidine) and metformin extended release.
While many of these drugs contained small amounts of the contaminant, the FDA expressed concern that the drugs could expose patients to unacceptable levels, potentially increasing the cancer risk over time.
Zantac recalls began in late 2019. Then in 2020, the FDA announced testing revealed levels of NDMA in ranitidine could increase over time, especially when the drug is stored above room temperature. On April 1, 2020, the FDA requested that manufacturers withdraw all ranitidine products from the U.S. market.
In June 2020, the FDA announced the first metformin extended release recalls for NDMA contamination.
“[NDMA was] definitely a strong focus pre 2020 and into 2020. We did just see nine NDMA recalls in Q3 from eight different companies,” Harvey said. “Most of those were related to metformin products … I do think that NDMA will continue to be a large focus for the [FDA] and that manufacturers need to focus on their foreign API suppliers and manufacturers and that we will continue to see those recalls throughout Q4 but also through the beginning of 2021.”
Learn More About Zantac Recalls
2. Johnson & Johnson’s Talcum Powder
Johnson & Johnson recalled 33,000 bottles of its iconic Johnson’s Baby Powder in October 2019 after the FDA had found small amounts of asbestos in a sample.
Faced with thousands of talcum powder cancer lawsuits and low sales, the company withdrew its talc-based baby powder from the U.S. market in May 2020.
“Demand for talc-based Johnson’s Baby Powder in North America has been declining due in large part to changes in consumer habits and fueled by misinformation around the safety of the product and a constant barrage of litigation advertising,” J&J said in a May 2020 statement.
Learn More About Talcum Powder Recalls
3. BD Alaris Systems
BD Alaris issued recalls for more than a million infusion pumps and pump modules in 2020 for software and hardware problems. Hospitals and health care facilities use the infusion pumps to deliver blood products and medications such as insulin, antibiotics, chemotherapy and pain relievers to patients.
“Three of the recalls, which BD announced on Aug. 4, 2020, have been designated as Class I recalls by the U.S. Food and Drug Administration (FDA), which means that FDA has determined that there is a reasonable probability that the use of the product will cause serious adverse health consequences or death,” according to the FDA’s September 2020 statement.
Learn More About BD Alaris Systems
4. Hand Sanitizer
Starting in June 2020, the FDA warned consumers that some hand sanitizers contained methanol or 1-propanol, toxic types of alcohol that can cause serious health problems including blindness and death. A handful of people have been hospitalized.
The FDA has recommended several companies issue recalls for their products, most of which were manufactured in Mexico.
Consumers can check the FDA’s website for a current list of sanitizers consumers should not use.
Recall Trend Predictions for 2021
Some of the recall trends — like recalls for contamination with NDMA — could continue into 2021, Chris Harvey, vice president of crisis solutions at Stericycle Expert Solutions, told Drugwatch. And there could be a spike in medical device recalls because of COVID-19 emergency use authorizations.
“I would predict that there could be some defects or safety concerns based on some of these looser regulatory requirements,” Harvey said. “Most companies will do the right thing no matter what, but I do think some suppliers will try to take advantage of some of these relaxed opportunities and shortcuts could be taken.”
The pandemic makes it more important for manufacturers to scrutinize suppliers and stay on top of audits and documentation — especially when it comes to suppliers of drug ingredients and APIs — Harvey said.
“Given everything going on with politics and COVID, it’s a lot of noise,” Harvey added. “So when a company has a recall, they have to take other steps to ensure that the hospitals and the patients are learning of the recall and taking action. We recommend companies use more multimodal recall communications during this time to ensure that consumers and patients tune in.”
Software, Manufacturing Deviations Top Reasons for Recalls
The top reason for medical device recalls in 2020 was software issues, according to Harvey. For pharmaceuticals, most recalls resulted from deviations in Current Good Manufacturing Practices (CGMPs).
“Software is the main driver with [medical device] recalls. It’s been the top reason for 17 of the last 18 consecutive quarters. I predict that will continue to be a large focus just as more of these devices become more connected,” Harvey said.