National Safety Recall - Aug. 12
There are several new FDA safety items worth flagging today, including one potentially fatal drug recall and an FDA warning about toxic weight-loss products.
Tyenne injection — glass particles could cause blood clots, organ damage or death
Fresenius Kabi is recalling one lot of Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL, after an internal investigation found glass particles in the medication.
FDA says injecting glass particles can cause pain, swelling and inflammation of veins. More seriously, particles can block blood vessels, cause blood clots or pulmonary embolism, permanently damage organs and potentially cause death. Tyenne is used for rheumatoid arthritis, giant cell arteritis, juvenile idiopathic arthritis and other serious conditions. (U.S. Food and Drug Administration)
The recall was announced August 10 and posted by FDA August 11. Health-care facilities and patients should check affected product before use and follow the recall instructions.
Weight-loss products contain poisonous yellow oleander
FDA today added three more products to its warning about botanical weight-loss supplements contaminated with toxic yellow oleander, a poisonous plant that can cause serious neurological, gastrointestinal and cardiovascular effects and can be fatal.
The newly identified products are Slim Elixir, D Magic Plus and B. Magi, all sold in 30-capsule bottles by Suerte Y Salud LLC. FDA testing found yellow oleander in all three. D Magic Plus also contains hidden diclofenac, which can cause life-threatening reactions, while B. Magi contains phenolphthalein, a substance associated with increased cancer risk. FDA says the seller has not responded to its calls or emails. (U.S. Food and Drug Administration)
Consumers should stop taking these products and dispose of them. FDA recommends contacting a health-care provider even if the product was taken some time ago; serious symptoms warrant emergency medical attention.
Schwarzkopf hair mousse — pressurized cans can explode
Henkel is recalling Schwarzkopf Professional Osis Grip Extra Strong Mousse, 6.76 ounces/200 mL, because defective packaging can allow the pressurized product to leak, creating an explosion hazard.
The recall covers 25 batch codes and products distributed in Alaska, Arizona, California, Florida, Michigan, Missouri, New Jersey, Ohio, Pennsylvania, South Carolina, Texas and Washington. Henkel received one consumer complaint and two reports from salons; one consumer reported bruising to the hand. Consumers should return affected cans for a refund. (U.S. Food and Drug Administration)
“Vegan” cheddar puffs — undeclared milk
Frankie's Organic Foods is recalling 94 cases of Frankie's Organic Plant-Based Vegan Cheddar Puffs because the supposedly vegan snack may contain undeclared milk, creating a potentially life-threatening risk for people with severe milk allergies.
Affected 4-ounce bags have Best If Used By May 16, 2027, UPC 816929000089, and lot code 05 16 2027. They were sold at PCC Markets in Washington, Earth Fare stores in Florida and South Carolina, and some independent retailers. The recall followed two allergic-reaction complaints involving related products in Canada. (U.S. Food and Drug Administration)
Other agency checks
CPSC: We found no new national CPSC recall dated August 11 or August 12. A Cuisinart food-processor recall appearing with an August 11 update is actually the longstanding 2016 recall, with consumer-contact information updated yesterday—not a new recall. (U.S. Consumer Product Safety Commission)
NHTSA: No new urgent nationwide vehicle-recall alert surfaced in today's official search. NHTSA continues to issue individual manufacturer recalls that may not receive separate press releases, so VIN checking remains worthwhile. (NHTSA)
USDA FSIS: No new meat, poultry or processed-egg recall dated August 11 or August 12 surfaced. The latest major FSIS activity remains the recent Listeria-related and jalapeño-related actions already covered in previous roundups. (Food Safety and Inspection Service)
The standout today is the FDA yellow-oleander warning. Unlike an ordinary recall, FDA says the seller of the three newly identified products has not responded, meaning potentially dangerous weight-loss capsules could remain in consumers' possession or in commerce. (U.S. Food and Drug Administration)
