The agency warns the public that the products may be a significant hazard to health.
Sometimes, taking care of our health involves more than just eating the proper things and working out frequently. We frequently turn to particular goods for a little additional assistance, whether it’s reaching into your medicine cabinet for some allergy relief medication or taking a prescription treatment to manage a persistent ailment. Nevertheless, sometimes the very same things that are supposed to keep us healthy or make us feel better might be flawed or harmful as a result of production errors or other defects. And currently, the Food & Drug Administration (FDA) has released a number of fresh advisories on the recall of medical products. Find out if you are impacted by the most recent agency notifications by reading on.
Hand sanitizer was recalled by a manufacturer due to a possible significant health risk.
The Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-sterile Solution and the Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Non-sterile Solution have been voluntarily recalled by Jarman’s Midwest Cleaning Solutions, Inc. of South Dakota, the FDA reported on March 28. The modification applies to all batches of the two products, which are advertised as a technique to reduce bacteria on the skin in between hand washings with soap and water.
The impacted goods were offered for sale in big 1-gallon clear or white plastic bottles, either individually or in cases of up to four. Its date of manufacturing, which ranges from March 24 to December 18, 2020, can also be used to identify them. The agency’s notification includes a comprehensive list of the distributors and NDCs for the products in question.
Following FDA testing that revealed the hand sanitizers to contain methanol, the business announced the recall. According to the EPA, “significant” exposure to the chemical can cause “death, nausea, vomiting, headache, blurred vision, coma, seizures, lifelong blindness, permanent central nervous system injury, or nausea and vomiting.” This is particularly dangerous for small children who mistakenly consume the product or for teenagers and adults who consume it as an alcohol replacement.
It is recommended that anyone who has the recalled hand sanitizer stop using it right away and dispose of the bottles “in compliance with local legislation.” Consumers can get in touch with the business for a return as well as with any inquiries or problems. Anyone who suspects they may have suffered from unfavourable health impacts after utilising the items should speak with their doctor right away.
Also mentioned in the most recent batch of warnings are medications. Atovaquone Oral Suspension, USP 750mg/5mL was voluntarily recalled by Camber Pharmaceuticals, Inc. of New Jersey on March 31, according to the FDA. To wholesalers, distributors, retail pharmacies, and mail-order pharmacies countrywide, the product was distributed.
The drug is supplied in 210mL plastic bottles and, according to the warning, is often given for the “prevention and treatment of Pneumocystis jiroveci pneumonia (PCP) in adults and children 13 years of age and older who cannot tolerate other drugs.” The NDC 31722-629-21, UPC 331722629218 and lot number E220182 on the affected products all have an expiration date of 12/2023.
The items may contain Bacillus cereus bacteria, according to the agency’s notification. This means that “there is a fair risk that atovaquone oral suspension microbial contamination can result in widespread, life-threatening infections such as endocarditis and necrotizing soft tissue infections” for anyone who is immunocompromised.
Anybody using the drug is advised by the manufacturer to stop doing so. They ought to call their doctor after discarding it or returning it to the store where it was purchased. Contacting the hotline or email address provided on the agency’s notification will put you in touch with the company if you have any concerns about the recall.
The most recent FDA advisories also mention a medical device. Abbott, a provider of medical supplies, has voluntarily decided to recall the Readers used with its FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Flash Glucose Monitoring Systems, the government declared on April 3. Together with a sensor worn on the back of the upper arm to gather real-time glucose readings, the items are used to treat diabetes.
The company allegedly announced the recall after receiving a “limited number of international reports” from customers over a period of years alleging that the readers’ lithium-ion batteries swelled, overheated, and “in extremely rare situations, ignited or caught fire.” The manufacturer makes it clear that FreeStyle Libre sensors are unaffected.
The message states that the readers are not being physically called back. Consumers may continue using them as long as they only use the yellow USB cord and adapter that included with the item to charge the reader batteries. The business claims that while third-party components may permit significantly more power, increasing the risk of fire, the Abbott USB cable and power adapter limit the current to safely charge the battery.
No “adverse health outcomes” or fatalities have been linked to the problem, according to the business, and “risks are mitigated” if Readers are stored, charged, and used properly. Consumers with inquiries can call Abbott’s customer care hotline at the number provided on the notification or visit the company’s specific website for more information.
There have been other recent instances of medical devices or pharmaceuticals being withdrawn from shelves due to safety concerns, in addition to the FDA’s most recent warnings. Dabigatran Etcxilate Capsules, USP, a frequently prescribed blood thinner drug, was voluntarily recalled by Ascend Laboratories LLC, the agency reported on March 22.
The action was taken in response to the company’s discovery that the medicine exceeded the FDA’s defined Acceptable Daily Intake (ADI) standards of a nitrosamine impurity, particularly N-Nitrosodimethylamine. The alert stated that although nitrosamines are frequently found in water and meals including grilled meats, dairy products, and vegetables, prolonged exposure to higher concentrations of them may raise the chance of developing cancer.
Furthermore, the pharmaceutical behemoth Pfizer Inc. issued a recall for its rimegepant drug marketed as Nurtec ODT on March 16 according to the U.S. Product Safety Commission (CPSC). In one instance, the medication—prescribed to patients to treat migraines—was taken off the market because it was not marketed in the legally required child-resistant packaging, posing a major poisoning risk.
- Source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/jarmans-midwest-cleaning-systems-inc-issues-voluntary-nationwide-recall-alcohol-antiseptic-80
- Source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/camber-pharmaceuticals-inc-issues-voluntary-nationwide-recall-atovaquone-oral-suspension-usp
- Source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/abbott-issues-safety-notification-freestyle-librer-family-readers-us
- Source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ascend-laboratories-llc-issues-voluntary-nationwide-recall-dabigatran-etexilate-capsules-usp-75-mg
- Source: https://www.cpsc.gov/Recalls/2023/Pfizer-Recalls-Nurtec-ODT-Prescription-Drugs-Due-to-Failure-to-Meet-Child-Resistant-Packaging-Requirement-Risk-of-Poisoning