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Showing 801–820 of 1571 results

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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

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 Non-Drowsy (Haleon) – Microbial Contamination (2023)

Microbial Contamination of Non-Sterile Products

FDADec 26, 2023Nationwide• Haleon US Holdings LLC

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

Microbial Contamination of Non-Sterile Products

FDADec 26, 2023Nationwide• Haleon US Holdings LLC

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

Presence of Particulate Matter; identified as glass

FDADec 21, 2023Nationwide• Pfizer Inc.

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

Presence of particulate matter: glass

FDADec 21, 2023Nationwide• PFIZER

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

Presence of Particulate Matter; identified as glass

FDADec 21, 2023Nationwide• Pfizer Inc.

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

Presence of Particulate Matter; identified as glass

FDADec 21, 2023Nationwide• Pfizer Inc.

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 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

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 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 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

Sertraline Tablets (Legacy) – Product Comingling Risk (2023)

CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.

Class IIModerate

FDADec 11, 2023AR, CA• Legacy Pharmaceutical Packaging LLC

Magnum XXL Capsules (Meta Herbal) – Undeclared Sildenafil (2023)

Undeclared Allergen

Marketed without an approved NDA/ANDA: Magnum XXL found to contain undeclared active pharmaceutical ingredient (API) - Sildenafil.

FDANov 29, 2023Nationwide• Meta Herbal

SANDIMMUNE Oral Solution (Novartis) – Crystallization Risk (2023)

Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals

FDANov 22, 2023Nationwide• Novartis Pharmaceuticals Corporation

KinderMed Kids' Acetaminophen (Kinder Farms) – Impurity Specs (2023)

Failed Impurities/Degradation Specifications

Class IIModerate

FDANov 13, 2023Nationwide• KINDER FARMS LLC

KinderMed Infants' Pain Acetaminophen (Kinder Farms) – impurity issue (2023)

Failed Impurities/Degradation Specifications

Class IIModerate

FDANov 13, 2023Nationwide• KINDER FARMS LLC

Tropicamide/Cyclopentolate Drops (Fagron) – labeling mix-up (2023)

Labeling: Label Mix-Up: The label of a dropper bottle mistakenly states the container is a 0.5mL single-use syringe instead of a 5 mL dropper

FDANov 10, 2023Nationwide• Fagron Compounding Services

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