Recent Food and Drug Administration regulations affecting small businesses

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.

Tornier HRS Max tuberosity body components (233 units) are subject to a Class II recall due to incorrect labeling causing incompatibility with the HRS Max system; affected products distributed nationwide across 32 US states.

Connecticut Crab Company LLC recalls approximately 175 pounds of crab cakes distributed to food service in New York and New Jersey due to potential temperature abuse and botulism risk.

Zarlengo Italian Ice recalls 173 one-gallon buckets of Double Dark Chocolate Gelato distributed in Illinois, Indiana, and Texas due to undeclared soy allergen in the product.

Riverence Provisions LLC recalls 306 cases of Smoked Trout Dip (3,672 units) distributed across eight states due to undeclared milk allergen on label, posing temporary health risks.

F&S Fresh Foods recalls 27 mislabeled ReadyMeals Turkey Bacon & Cheddar Pretzel Duo Sandwiches (10 oz) in Oregon due to undeclared sesame allergen posing potential temporary health risks.

Blueroot Health's Vital Nutrients Aller-C supplement recall affects 11,849 bottles nationwide due to undeclared egg, soy, and hazelnut allergens.