Health and Healthcare

10 Most Recent Medical Safety Recalls - October 3, 2023

courtesy of the U.S. Food and Drug Administration

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.”

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. (These are the 17 worst myths about boosting metabolism.)

The following list of FDA recalls will be updated when the FDA posts new reports.

Nasal Spray Recalled

On September 29, Biomic Sciences initiated a voluntary recall of all lots of ION* Sinus Support, ION* Biome Sinus, and Restore Sinus Spray products. Microbial contamination raises “a reasonable probability that the use of the affected product could potentially result in severe or life-threatening adverse events …. ” No reports of such events have been reported yet. 

Betaxolol Tablets Recalled for Possible Oxycodone Contamination

On September 29, KVK-Tech initiated a voluntary recall of one lot of Betaxolol Tablets, USP 10 mg. The recall is a precautionary measure taken after one Oxycodone HCl tablet 5 mg foreign tablet was found on the packaging line after the lot had been packaged. An oxycodone tablet inadvertently taken instead of a Betaxolol tablet by some elderly patients could worsen a potential heart-slowing side effect of the Betaxolol. Additionally, “Specific patient populations such as those with opioid use disorder (OUD) or at risk of OUD, infants, children, and the elderly are likely to be negatively affected by inadvertently receiving an opioid, especially if a substantial number of oxycodone tablets have been introduced into a bottle labeled as betaxolol.”  

Vaginal Anti-Fungal Tablets Recalled

On September 28, Scynexis Inc. voluntarily recalled 2 lots of its Brexafemme antifungal product for the treatment of vulvovaginal candidiasis (VVC) and the reduction of the incidence of recurrent vulvovaginal candidiasis (RVVC) due to cross-contamination risk. The company has received no reports of adverse reactions due to the possible contamination. The recalled lots were distributed nationwide. Instructions for returning the product are available in the FDA recall notice

Ulcer Medication Recalled

On September 22, VistaPharm LLC voluntarily issued a recall of one lot of Sucralfate Oral Suspension, 1g/10mL, due to Bacillus cereus contamination. The company has received no reports of adverse events related to this recall. This product is only available by prescription. Details of the recalled lot and how the recall is being handled are available in the FDA alert. 

Universal Meditech Recalls All Products

On September 22, expanded a recall first issued on May 23 (see “Do Not Use These Tests”, below). The expanded recall applies to all the company’s products. UMI is going out of business UMI distributed the products to distributors in California, New York, New Jersey, and Florida, and these products may have been further sold to end consumers national-wide across the United States. A full list of the recalled products is available in the FDA’s notice from September 22. 

Kraft American Cheese Singles Recalled

On September 19, Kraft Heinz Co. issued a voluntary recall of about 83,800 cases of individually wrapped Kraft American Singles processed cheese slices. It is possible that a thin strip of the wrapping may remain on the cheese after the wrapper has been removed:  “If the film sticks to the slice and is not removed, it could be unpleasant and potentially cause a gagging or choking hazard.” See the recall notice for more details.  

Non-sterile Addipak Saline Solution Recalled

On September 20, the FDA issued a recall on Hudson RCI Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution that can be used for inhalation or irrigation theory of the lungs. This is a Class I recall, the most serious type of recall, because continued use of the product may cause serious injuries or death. Medline Industries is recalling one lot of the drug (#3B085) because it is not sterile. There are no reports of injury or death related to this issue.

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.

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