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Multichem ID-B (Techno-Path) – HBsAg Recovery Issue (2025)

Potential of negative recovery of the HBsAg analyte across two (2) lots of Multichem ID-B Positive Control when tested on the Alinity i platform.

Moderate

FDAOct 17, 2025CA, CO, CT +14 more• TECHNO-PATH MANUFACTURING LTD. Fort Henry Business Park Ballina Tipperary Ireland

Acetaminophen Caffeine Caplets (Aero) – Labeling Mix-up (2025)

Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAID)*500mg and Caffeine 32.5mg.

Class IIModerate

FDAOct 17, 2025Nationwide• Aero Healthcare

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Multichem ID-B (Techno-Path) – HBsAg Recovery Issue (2025)

Acetaminophen Caffeine Caplets (Aero) – Labeling Mix-up (2025)

IntelePACS (Intelerad) – Software Communication Bug (2025)

Prazosin Hydrochloride 5mg Capsules (Amerisource) – Impurity Risk (2025)

Prazosin Hydrochloride 1mg Capsules (Amerisource) – Impurity Risk (2025)

Cinnamon Powder (Homeneeds) - Elevated Lead Levels (2025)

Egg with Green Salsa Burrito (M.C.I. Foods) - Listeria Contamination (2025)

VANTAGE GALAN 3T (Canon Medical) – Electrode Distance Compliance (2025)

Prazosin Hydrochloride 2mg Capsules (Amerisource) – Impurity Risk (2025)

Ceiling Type X-Ray Tube Support (Shimadzu) – Mounting Shaft Risk (2025)

Cinnamon Whiskey Pecans (Nats Nuts) - Undeclared Cashews (2025)

Egg and Cheese Breakfast Burrito (M.C.I. Foods) - Listeria Contamination (2025)

Semaglutide 6mg Injection (ProRx) – Sterility Concern (2025)

Tuna Deluxe (Lo-Boy Foods) - Listeria Contamination (2025)

Semaglutide 5mg Injection (ProRx) – Sterility Concern (2025)

Semaglutide 10mg Injection (ProRx) – Sterility Concern (2025)

Semaglutide 8mg Injection (ProRx) – Sterility Concern (2025)

Tirzepatide 27mg Injection (ProRx) – Sterility Concern (2025)

Semaglutide 2.5mg Injection (ProRx) – Sterility Concern (2025)

Macaroni Salad (Lo-Boy Foods) - Listeria Contamination (2025)