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Showing 801–820 of 1639 results

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Glimepiride Tablets 1mg 500-count (Dr. Reddy's) – Tablet Misprint (2024)

Misprint on tablet

Class IIILow

FDAJan 18, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

Fosfomycin Tromethamine Granules (Ascend) – Impurity Specification (2024)

Failed Impurities/Degradation Specification: Out of specification for organic impurities

Class IIModerate

FDAJan 16, 2024Nationwide• Ascend Laboratories, LLC

Vasopressin Sodium Chloride (IntegraDose) – Subpotent Drug (2024)

Subpotent Drug

Class IIModerate

FDAJan 12, 2024MN• IntegraDose Compounding Services LLC

Vasostrict (Par Sterile Products) – Superpotent Drug (2024)

Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.

Class IIModerate

FDAJan 11, 2024Nationwide• Par Sterile Products LLC

Budesonide Tablets (Teva) – Failed Dissolution (2024)

Failed Dissolution Specifications

Class IIModerate

FDAJan 8, 2024Nationwide• Teva Pharmaceuticals USA, Inc

Ibuprofen Famotidine Tablets (Ascend) – Foreign Tablet (2023)

Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.

Class IIModerate

FDADec 29, 2023Nationwide• Ascend Laboratories, LLC

Bupropion XL Tablets (Rising Pharma) – Foreign Tablets (2023)

Presence of Foreign Tablets/Capsules

Class IIModerate

FDADec 29, 2023Nationwide• Rising Pharma Holding, Inc.

DELFLEX Peritoneal Dialysis Solution (Fresenius) – Sterility Concern (2023)

Lack of Sterility Assurance

Class IIModerate

FDADec 28, 2023Nationwide• Fresenius Medical Care Holdings, Inc.

Benzonatate Capsules (Amerisource) – Superpotent Drug (2023)

Superpotent drug: Assay results were slightly above specification at the time zero point.

Class IIILow

FDADec 26, 2023Nationwide• Amerisource Health Services LLC

Robitussin Honey CF Max Nighttime (Haleon) – Microbial Contamination (2023)

Microbial Contamination of Non-Sterile Products

Class IHigh

FDADec 26, 2023Nationwide• Haleon US Holdings LLC

Robitussin Honey CF Max Non-Drowsy (Haleon) – Microbial Contamination (2023)

Microbial Contamination of Non-Sterile Products

Class IHigh

FDADec 26, 2023Nationwide• Haleon US Holdings LLC

Sodium Bicarbonate Injection (Pfizer) – Glass Particulate Matter (2023)

Presence of Particulate Matter; identified as glass

Class IHigh

FDADec 21, 2023Nationwide• Pfizer Inc.

Atropine Sulfate Injection (Pfizer) – Glass Particulate Matter (2023)

Presence of Particulate Matter; identified as glass

Class IHigh

FDADec 21, 2023Nationwide• Pfizer Inc.

Sodium Bicarbonate Injection (Pfizer) – Glass Particulate Matter (2023)

Presence of Particulate Matter; identified as glass

Class IHigh

FDADec 21, 2023Nationwide• Pfizer Inc.

Bleomycin Injection (Pfizer) – Glass Particulate Matter (2023)

Presence of particulate matter: glass

Class IHigh

FDADec 21, 2023Nationwide• PFIZER

Selenium Sulfide Shampoo (Private Label) – Stability Concerns (2023)

CGMP Deviations: Stability data does not support expiry date.

Class IIModerate

FDADec 13, 2023NJ• Private Label Partners, Inc.

Nystatin Powder 2 BU (Fagron) – Incorrect Strength Label (2023)

Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.

Class IIModerate

FDADec 11, 2023Nationwide• Fagron, Inc

Nystatin Powder 150 MU (Fagron) – Incorrect Strength Label (2023)

Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.

Class IIModerate

FDADec 11, 2023Nationwide• Fagron, Inc

Nystatin Powder 500 MU (Fagron) – Incorrect Strength Label (2023)

Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.

Class IIModerate

FDADec 11, 2023Nationwide• Fagron, Inc

Nystatin Powder 5 BU (Fagron) – Incorrect Strength Label (2023)

Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.

Class IIModerate

FDADec 11, 2023Nationwide• Fagron, Inc

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