FDA regulations

Brahms GmbH recalls Class II diagnostic test catalog 859075N due to out-of-range quality control values that may produce falsely elevated results if not properly troubleshot per instructions.

FDA holds public meeting on expanding nonprescription drug access and requests stakeholder comments; no specific deadline or financial impact stated for small businesses.

Teva Pharmaceuticals recalls 8,376 packages of Isotretinoin Capsules due to superpotent and subpotent batches in Florida, Ohio, Puerto Rico, and Mississippi.

Fagron Compounding Services recalls 16,130 bags of vancomycin HCI and four other sterile products nationwide due to failed sterility assurance and potential port detachment risks.

Teva Pharmaceuticals USA recalls 62,136 cartons of Clonidine Transdermal System and two other products due to unapproved raw material use; Class II recall distributed within the U.S.

Cook Medical recalls 20 units of Arterial Pressure Monitoring Trays (APMY series) distributed worldwide due to expiration date labeling exceeding true shelf life, posing temporary health risks.

Fresenius Kabi USA recalls 0.9% Sodium Chloride Injection and 13 other products nationwide due to lack of sterility assurance, posing potential temporary or reversible health risks.

GE Healthcare Ireland Limited recalls 306,810 vials of Omnipaque (iohexol) injection nationwide due to particulate matter that may cause temporary or reversible health problems.

Cipla USA recalls Lanreotide Injection 120 mg/0.5 mL nationwide due to sterility assurance deficiencies at the contract manufacturer's visual inspection procedure.

Viatris recalls Xanax XR 3 mg alprazolam extended-release tablets nationwide due to failed dissolution specifications that may cause temporary or reversible health problems.

Preferred Pharmaceuticals recalls 720 nationwide bottles of Geri-Care artificial tears lubricant eye drops due to lack of sterility assurance, classified as a Class II recall posing temporary or reversible health risks.

XTANT Medical recalls 2 units of Xpress Pedicle Screw System (Part X073-6555-DL) in Oregon due to mislabeling that misidentifies screw length, a Class II issue causing potential temporary health complications.

Stryker Sustainability Solutions recalls 56,740 tourniquet cuffs nationwide due to potential detachment at welding connections that could compromise pressure maintenance.

Siemens Medical Solutions ARTIS pheno and ARTIS Icono biplane X-ray systems (models 10849000, 11327600, 11328100, 11327700) are subject to a Class II recall due to sporadic display errors showing incorrectly elevated dose readings during patient exa…

Beckman Coulter recalls 688 boxes of MicroScan Neg MIC 3J panels distributed in Japan due to manufacturing defects causing incorrect antibiotic concentrations in well 4/4.