FDA regulations

Remel Inc. issued a Class II recall for Yeastone Broth (2,819 units distributed worldwide) due to potential incorrect AST results during quality control that may delay antifungal treatment responses.

Avantor Performance Materials recalls 36 bottles of subpotent magnesium chloride hexahydrate API distributed nationwide in the USA, Belgium, and France in a Class III recall unlikely to cause health problems.

Wilson-Cook Medical Inc. issued a Class II recall of 713,702 Instinct Plus Endoscopic Clipping Devices nationwide due to potential malfunction risk.

Clariance-SAS recalls 511 Elegance cervical plates nationwide due to burrs that may cause temporary health problems; affected states include California, Illinois, New York, and Texas.

FDA classifies mandibular-movement-based sleep apnea testing devices as Class II medical devices subject to special controls to ensure safety and effectiveness while reducing regulatory burden.

Sun Pharmaceutical recalls 41,712 tubes of Fluocinonide USP 0.05% cream nationwide due to failed viscosity specifications identified during stability testing.

Payless Compounders LLC recalls 91 vials of compounded semaglutide-glycine-cyanocobalamin injectable due to lack of sterility assurance; distributed in Oregon.

Cipla USA recalls 113,336 bottles of Cinacalcet Hydrochloride Tablets nationwide due to CGMP deviations and N-Nitroso impurities exceeding acceptable daily intake limits.

Arjo Tenor mobile passive patient lift models KHA1000 US and KHA1010 US are subject to a Class II recall affecting 119 units nationwide due to actuator components that may fail suddenly, causing uncontrolled descent of the lifting arm.

Medline Industries recalls 640 CENTURION Circumcision Kits (SKU CIT7050F) distributed in South Carolina due to lack of required sterilization process, posing temporary health risks.

Owen Biosciences recalls 7,975 tubes of FHF Farmhouse Fresh acne treatment products nationwide due to benzene contamination posing temporary health risks.

FDA classifies the setmelanotide eligibility gene variant detection system as class II medical device with special controls to ensure safety and effectiveness for clinical chemistry and toxicology applications.

B Braun Medical recalls 328,640 hemodialysis bloodline units (SL-2000M2095L and related models) distributed nationwide and in Canada due to potential air bubble accumulation that may cause serious injury or death.

International Medication Systems Ltd. recalls 81,520 units of Epinephrine Injection nationwide due to lack of sterility assurance, classified as a Class II recall posing temporary health risks.

FDA classifies digital therapy devices for amblyopia as Class II medical devices, requiring special controls to ensure safety and effectiveness while reducing regulatory burdens for this ophthalmic category.