Gold Star Distribution Inc., Issues Recall of Certain FDA-Regulated Products in Three States Including Drugs, Devices, Cosmetics, Human Foods, and Pet Foods

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Misbranded

Certain Codman Disposable Perforators may disassemble during or after use, increasing the risk of brain injury, hemorrhage, or prolonged surgery.

Laboratory Manual of Quality Policies (ISO 17025 Requirements)

The Food and Drug Administration is announcing the availability of a final guidance for industry entitled “E6(R3) Good Clinical Practice.” This revision incorporates flexible, risk-based approaches and embraces innovations in trial design, conduct, and technology.

FDA recognizes that there are some patients with severe gastrointestinal motility disorders that are difficult to manage with available therapy for whom domperidone’s potential benefits may justify its potential risks. Patients 12 years of age and older with certain gastrointestinal (GI) conditions

P. East Trading Corp. of Bronx, NY is recalling Salted Smoked Split Herring because the product was found to be over 5″ in length and uneviscerated, as such having potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumer