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Daily 30+ Prebiotic Blend (Zoe) – Foreign Objects (2024)

Product may contain foreign objects: small metal pieces and/or stones

FDADec 4, 2024AZ, CA, CO +23 more• Zoe US, Inc.

Duloxetine Capsules 30mg (PD-Rx) – Nitrosamine Impurity (2024)

CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit

Class IIModerate

FDADec 4, 2024FL, MS, WI• PD-Rx Pharmaceuticals, Inc.

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Daily 30+ Prebiotic Blend (Zoe) – Foreign Objects (2024)

Duloxetine Capsules 30mg (PD-Rx) – Nitrosamine Impurity (2024)

Nitrofurantoin Capsules 100mg (AvKARE) – Dissolution Failure (2024)

Mi More Snacks (San Miguel) – Labeling Issue (2024)

Organic Pecan Halves (Pecan Star) – Undeclared Walnuts (2024)

UNiD Spine Analyzer (Unknown) – Rod Planning Software Error (2024)

ECONO STERILE Surgical Scissors (Sklar) – Packaging Sterility Breach (2024)

ECONO STERILE Medical Kits (Sklar) – Packaging Sterility Breach (2024)

Neptune 3 Rover (Stryker) – Vacuum Pump Filter Housing Issue (2024)

ECONO STERILE Trousseau Dilator (Sklar) – Packaging Sterility Breach (2024)

FastPack SHBG Immunoassay (Qualigen) – Incorrect Expiration Date (2024)

Donor Human Milk (MN Milk Bank) – Foreign Material (2024)

Jalapeno Cheese Puffs (Wegmans) – Undeclared Ingredients (2024)

Golden Bavarian Creme Filling (BakeMark) – pH Deviation (2024)

VerifyNow P2Y12 Platelet Test (Accriva) – Market Clearance Issue (2024)

Folysil Foley Catheters (Coloplast) – Sterility Concern (2024)

Change Healthcare Cardiology Software (ALI Technologies) – Medication Error Risk (2024)

Headway Microcatheter (MicroVention) – Inner Packaging Seal Defect (2024)

X-Flow Prostatectomy Catheter (Coloplast) – Sterility Issue (2024)

Grecian Delight Tzatziki Sauce (Grecian Delight) – Salmonella Risk (2024)