The U.S. Food and Drug Administration (FDA) issues safety alerts as needed to provide timely new safety information on human drugs, medical devices, vaccines, and other products, including biologics, dietary supplements, and cosmetics. The alerts are publicly available at the agency’s MedWatch website and contain “actionable information that may impact both treatment and diagnostic choices for healthcare professional and patient.” (These are the biggest health mistakes people make in the summer.)
The FDA’s Food Safety and Inspection Service and the Centers for Disease Control and Prevention maintain a website with updated information on food safety recalls. The list updates automatically when a recall notice is issued.
The following list of FDA recalls will be updated when the FDA posts new reports.
Children’s TheraBreath Oral Rinse Recalled
On September 8, the FDA reported that Church and Dwight Co. began a voluntary recall of one specific lot of its TheraBreath Kids Strawberry Splash oral rinse (16 oz.) after discovering the product was contaminated with yeast. This lot was sold exclusively on Amazon.com between May 13 and September 2 of this year. The company said it is not aware of any illness or injury reports to date. Consumers should stop using the product and contact the company before discarding it in order to receive a full refund.
Novartis Recalls Sandimmune Oral Solution
On September 11, Novartis announced a voluntary recall of one lot of its Sandimmune Oral Solution (cyclosporine oral solution, USP), 100 mg/mL in the United States. The drug is used for prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants, and may also be used in the treatment of chronic rejection in patients previously treated with other immunosuppressive agents. Distribution of this lot began in April 2023, and Novartis is sending a recall notification letter to distributors, retailers, and consumers.
WEFUN Capsules Recalled
On September 5, the FDA reported that WEFUN Inc. will voluntarily recall 300 boxes of WEFUN Capsules after the FDA found that the product was tainted with sildenafil, an active ingredient in FDA-approved products fo the treatment of male erectile dysfunction. Consumers is notifying distributors and consumers by email how to return the product.
Mislabeled Heart Treatment Drugs Recalled
On August 31, the FDA reported that Marlex Pharmaceuticals Inc. is voluntarily recalling one lot each of Digoxin Tablets USP, 0.125mg and 0.025 mg, due to a labeling issue that mixed up the labels of the two heart failure treatment products. The labeling error could cause either overdosing or underdosing. Digoxin increases “increases heart muscle contraction in pediatric patients with heart failure” and is indicated for adults with chronic atrial fibrillation.
Universal Meditech Inc. Recalls All Products Made Between March 2021 and November 2022
On August 28, the FDA reported that Universal Meditech Inc. was recalling all products that the company was going out of business and would not be able to continue fulfilling any post-market responsibilities three products (PrestiBio Breastmilk Alcohol Test Strip, PrestiBio™ Ketone Test Strips, and HealthyWiser KetoFast™ Ketone Test Strips). All have been distributed without appropriate premarket clearance or approval, and potentially could result in inaccurate test results due to lack of performance evaluation by the FDA.
Dr. Berne’s MSM Eye Drops
On August 26, the FDA announced that Dr. Berne’s Whole Health Products is voluntarily recalling all lots of MSM Drops 5%,15% Solution, Dr. Berne’s Organic Castor Oil Eye Drops, and Dr. Berne’s MSM MIST 15% Solution. One lot of the 5% MSM Drops were found to be contaminated. According to the FDA, “Using contaminated eye drops could result in minor to serious vision-threatening infection which could possibly progress to a life-threatening infection.” Consumers who have any of these products should stop using them and return them to Sun Star Organics, 988 Main Street, Orange, CA 92867.
Do Not Use These Tests
On August 11, the FDA warned consumers and patients not to use tests manufactured by Universal Meditech Inc. (UMI). The company notified the FDA that it has stopped all operations and is no longer providing support for its tests. The FDA is not able to confirm the performance of UMI’s tests, raising concerns that the tests may not be safe and effective. The products have been recalled by UMI from its distributors, but UMI did not issue a recall notice to consumers. See the FDA Safety Communication for a list of the products covered by this notice.
Tydemy Oral Contraceptive Recalled
On July 28, Lupin Pharmaceuticals voluntarily recalled two lots of its Tydemy oral contraceptive due to out-of-specification test results. One lot tested low for ascorbic acid (an inactive ingredient) and high for a known impurity. According to the company, “Patients taking Tydemy are advised to continue taking their medication and immediately contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment.” The company is notifying its distributors and customers to arrange for a return of the recalled product lots.
Medtronic Implantable Cardiac Devices Recalled
On July 18, the FDA announced a recall of 348,616 implantable cardiac devices made and sold by Medtronic under a number of brand names. The devices were distributed between October 2017 and June 2023. This is a Class I recall, indicating the use of the devices may cause serious injury or death. The company reports 28 incidents, 22 injuries, and no deaths related to this recall. The company initiated the recall on May 10, 2023.
Do Not Use RoyalVibe Health, CellQuicken, or Well-Being Reality Ultrasound Devices
On July 17, the FDA warned consumers not to use ultrasound devices manufactured and distributed by RoyalVibe Health, CellQuicken, or Well-Being Reality. According to the FDA, the devices have not been reviewed for safety and effectiveness and may result in adverse effects, including pain, burns, and nerve damage, among others. The FDA recommends that consumers not buy or use these devices and should instead seek professional medical care. In late December 2022, the FDA sent a warning letter to the CEO of the three companies regarding the devices.
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