FDA regulations

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.

Medline Industries recalls 2,980 medical convenience kits containing NAMIC angiographic rotating adapter syringes due to risk of adapter unwinding causing disconnection during use; distributed nationwide in US, Puerto Rico, Canada, Netherlands, and …

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.

FDA seeks public comments on financial transparency and efficiency of prescription drug, biosimilar, and generic drug user fee programs at a public meeting.

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.

FDA draft guidance recommends next-generation sequencing methods for nonclinical safety assessment of investigational human genome editing products in gene therapy.

FDA Class I recall of Blue Bull Extreme Male Enhancement Supplement by Pure Vitamins and Natural Supplements, LLC for undeclared sildenafil; distributed in New Jersey.

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.

FDA determines BILTRICIDE (praziquantel) 600mg oral tablets were not withdrawn for safety or effectiveness reasons, allowing continued approval of generic versions meeting regulatory requirements.

FDA seeks 60 days of public comment on proposed information collection requirements for color additive certification under the Paperwork Reduction Act.

FDA requests 60-day public comment on information collection requirements for food and color additive petitions, master file submissions, and Form FDA 3503 electronic filings.

FDA is withdrawing approval of GlaxoSmithKline's Wellcovorin (leucovorin calcium) tablets in 5 mg and 25 mg strengths due to the applicant's request following market discontinuation.

FDA seeks 60-day public comment on information collection requirements for premarket approval of medical devices under the Paperwork Reduction Act.