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Sertraline Hydrochloride Tablets (Lupin) – defective container (2025)

Defective container - seal not adhering to bottles

FDANov 5, 2025Nationwide• Lupin Pharmaceuticals Inc.

Hemochron Activated Clotting Time Low-Range Test Cuvette,... (Accriva Diagnostics, Inc.) – foreign object (2025)

Test cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign object that has sharp edges and could pose a risk of injury if not detected prior to handling.

Moderate

FDANov 5, 2025Nationwide• Accriva Diagnostics, Inc.

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Sertraline Hydrochloride Tablets (Lupin) – defective container (2025)

Hemochron Activated Clotting Time Low-Range Test Cuvette,... (Accriva Diagnostics, Inc.) – foreign object (2025)

Oven Dried Fish (African Food on Wheels) – Botulinum Risk (2025)

Onion Granules (Laiwu Manhing) – Foreign Objects (2025)

Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10. (Cepheid) – product testing did not meet expected... (2025)

Brand Name: Diasol Product Name: 100225-10-DEX100, Liqui... (Diasol, Inc) – safety and efficacy of dialysis acid ... (2025)

Organic Moringa Leaf Powder (Africa Imports) – Salmonella Contamination (2025)

Cardiosave Hybrid. Intra-Aortic Balloon Pump system. (Datascope Corp.) – the ifu addendum revises the preventa... (2025)

Cardiosave Rescue. Intra-Aortic Balloon Pump system. (Datascope Corp.) – the ifu addendum revises the preventa... (2025)

Iodine Test (Get Tested International) – unapproved distribution (2025)

Organic Acids Profile Test Large (Get Tested International) – unapproved distribution (2025)

DHEA Test (Get Tested International) – unapproved distribution (2025)

Allergy Test IgE (Get Tested International) – unapproved distribution (2025)

Food Intolerance Test Medium (Get Tested International) – unapproved distribution (2025)

Herpes (HSV-1 & HSV-2) Test (Get Tested International) – unapproved distribution (2025)

MPOX Test (GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden) – distribution without premarket approv... (2025)

Food Intolerance Test Large (Get Tested International) – unapproved distribution (2025)

Organic Acids Test (Get Tested International) – unapproved distribution (2025)

Candida Test (Get Tested International) – unapproved distribution (2025)

Food Sensitivity Test Large (Get Tested International) – unapproved distribution (2025)