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Showing 521–540 of 68218 results

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Duloxetine Capsules 60mg (Breckenridge) – Impurity Concerns (2025)

CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.

Class IIModerate

FDAOct 9, 2025Nationwide• Breckenridge Pharmaceutical, Inc.

FentaNYL Citrate PF Injection (STAQ Pharma) – Labeling Error (2025)

Labeling: Incorrect or Missing Lot and/or Exp Date

Class IIILow

FDAOct 9, 2025Nationwide• STAQ Pharma, Inc.

ShockPulse Lithotripsy Transducer (Olympus) – startup failure (2025)

The device may either fail to start up, or the transducer may start briefly and then stop, accompanied by an error light on the generator. In addition, the body of the transducer handpiece may gradually increase in temperature during clinical use.

Moderate

FDAOct 8, 2025Nationwide• Olympus Corporation of the Americas

ACUSON Imaging Catheter (Sterilmed) – reprocessing cycles (2025)

Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or mechanical integrity of the device and can lead to severe adverse events such as infection, vascular injury or embolism.

Moderate

FDAOct 8, 2025Nationwide• Sterilmed, Inc.

Fusia Veggie Spring Rolls (Tai Foong) – undeclared shrimp (2025)

Undeclared Allergen

Undeclared shrimp

Class IHigh

FDAOct 8, 2025AL, CT, DE +21 more• Tai Foong USA Inc

Sprouts Smoked Mozzarella Pasta Salad – listeria risk (2025)

Listeria

Product may contain Listeria monocytogenes.

Class IHigh

FDAOct 8, 2025AL, AZ, CA +22 more• Sprouts Farmers Market

Fasenra Injection (AstraZeneca) – Sterility Risk (2025)

Lack of Assurance of Sterility:

Class IIModerate

FDAOct 8, 2025Nationwide• ASTRAZENECA PHARMACEUTICALS

ACUSON ACUNAV Catheter (Sterilmed) – Reprocessing Integrity Risk (2025)

Moderate

FDAOct 8, 2025Nationwide• Sterilmed, Inc.

Digital Cell Morphology Analyzer (Cellavision) – Barcode Reading Error (2025)

Automated cell-locating device barcode reader may read the barcode of the previously processed slide resulting in a misattribution of diagnostic results.

Moderate

FDAOct 8, 2025Nationwide• Cellavision AB Forskningsbyn Ideon Scheelevagen 19a Lund Sweden

Group B Streptococcus Test (Meridian) – tube cap defect (2025)

The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.

Moderate

FDAOct 7, 2025AL, CO, FL +11 more• Meridian Bioscience Inc

Alethia C. Difficile Test (Meridian) – tube cap defect (2025)

The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.

Moderate

FDAOct 7, 2025AL, CO, FL +11 more• Meridian Bioscience Inc

Ground Ginger 16 oz (Eagle Spice) – Elevated Lead Levels (2025)

Contains elevated levels of lead (Pb)

Class IIModerate

FDAOct 7, 2025CT, NJ, NY +1 more• Eagle Spice and Extract Co., Inc.

Loaded Veggie Grain Bowl (Nutrition for Longevity) – listeria risk (2025)

Listeria

Potential contamination with Listeria monocytogenes.

Class IIModerate

FDAOct 7, 2025CA, DE, FL +8 more• Nutrition for Longevity

TRUE METRIX Blood Glucose Meter (Trividia) – LCD display issues (2025)

Manufacturing defect causing LCD display issues with missing or partial segments (ghosting) that can result in misreading glucose values, potentially leading to inappropriate treatment decisions for diabetes management.

Moderate

FDAOct 7, 2025Nationwide• Trividia Health, Inc.

Prazosin Hydrochloride Capsules 2mg (Teva) – Impurity Concerns (2025)

CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.

Class IIModerate

FDAOct 7, 2025Nationwide• Teva Pharmaceuticals USA, Inc

Loaded Veggie Grain Bowl (FreshRealm) – listeria risk (2025)

Listeria

Potential contamination with Listeria monocytogenes

Class IIModerate

FDAOct 7, 2025CA, DE, FL +8 more• FreshRealm

Prazosin Hydrochloride Capsules 5mg (Teva) – Impurity Concerns (2025)

CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.

Class IIModerate

FDAOct 7, 2025Nationwide• Teva Pharmaceuticals USA, Inc

Carbidopa Levodopa Entacapone Tablets (Rising Pharma) – Product Mix-up (2025)

Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150 mg/200 mg) instead of labelled lower strength Carbidopa, Levodopa, and Entacapone film-coated tablets (25 mg/100 mg/200 mg).

Class IIModerate

FDAOct 7, 2025Nationwide• Rising Pharma Holding, Inc.

Pastured Grade AA Large Eggs (Kenz Henz) – Salmonella Contamination (2025)

Salmonella

Eggs may be contaminated with Salmonella.

Class IHigh

FDAOct 7, 2025TX• Kenz Henz LLC

Prazosin Hydrochloride Capsules 1mg (Teva) – Impurity Concerns (2025)

CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.

Class IIModerate

FDAOct 7, 2025Nationwide• Teva Pharmaceuticals USA, Inc

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