November was a big month for U.S. Food and Drug Administration (FDA) recalls. In addition to the ongoing hand sanitizer recalls, the federal agency has issued recalls of the following drugs and devices.
1. Dexmedetomidine Hydrochloride Injections
Fresenius Kabi recalled a single lot of an injectable sedative after discovering lidocaine contamination. Lidocaine is an anesthetic that may cause an allergic reaction in some patients. Doctors typically administer Dexmedetomidine HCl intravenously (in an IV) before and during surgery. The recall was announced on November 19, 2020. So far, the FDA has not received reports of any adverse drug experiences.
2. Trevo XP ProVue Retriever
Stryker Neurovascular initiated a Class I recall* of a device intended to treat blood clots on September 21, 2020. According to the FDA, the Trevo XP ProVue Retriever device is designed to “restore blood flow or remove blood clots within a blood vessel in the brain during an acute ischemic stroke.”
Stryker recalled the device because the core wire can separate or break during use, thus leaving the device inside the patient’s blood vessel or tissue. Broken devices can cause serious consequences, including bleeding, additional blockage of blood vessels, disability, and death.
As of November 9, 2020, the FDA has received 11 reports of injury or illness and one report of death.
*Class I recalls are the most serious type of FDA recall.
3. Medtronic Heart Catheter
Rashkind Balloon Septostomy Catheters are designed to treat patients with cyanotic congenital heart defects (heart defects that are present at birth). On August 24, Medtronic recalled 142 of these devices with a Class I recall due to quality issues that may cause the device to break, separate, or fail during use.
When Medtronic heart catheters fail, patients can suffer vascular injury (damage to the blood vessels) and death. As of November 3, 2020, the defective medical device has injured 2 patients and killed 1 other.
Like Zantac, metformin was recalled due to N-nitrosodimethylamine (NDMA) contamination. NDMA is a “probable human carcinogen,” or a substance that likely causes cancer in humans. The FDA first began investigating NDMA in metformin in December of 2019, and companies began recalling extended-release metformin this summer.
The latest company to recall metformin is Nostrum Laboratories, which issued its recall on November 4, 2020. Because metformin is a diabetes drug, the FDA advises patients to talk to their healthcare provider before stopping or switching medications.
5. Sunstar Oral Rinse
Sunstar Americas, Inc. issued a voluntary recall for its Paroex® Chlorhexidine Gluconate Oral Rinse USP on October 27, 2020. The prescription rinse is designed to treat gingivitis, but the recalled products may be contaminated with the bacteria Burkholderia lata. Due to this defect, the product could cause oral and systematic infections, which may require antibacterial treatments. While patients in the most at-risk populations could develop life-threatening infections, including pneumonia and bacteremia, no adverse events had been reported as of October 28, 2020.
What To Do If You’ve Been Affected By a Dangerous Drug or Medical Device
Suffering an adverse event due to a drug or medical device is never acceptable. If you’ve been harmed by one of the drugs or devices above, please report your experience to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
You should also know that you may be entitled to compensation. Lauri J. Goldstein & Associates, PLLC can walk you through your rights and legal options during a free consultation.
We are available 24/7, so all you need to do is call us at (866) 675-4427 or contact us online to get started today.