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Showing 821–840 of 1639 results

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

Failed Impurities/Degradation Specifications

Class IIModerate

FDANov 13, 2023Nationwide• KINDER FARMS LLC

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

SugarMD Glucose Support Capsules (SUGARMDS) – Undeclared Medication (2023)

MARKETED WITHOUT AN APPROVED NDA/ANDA: Product found to be tainted with metformin and glyburide

FDANov 8, 2023Nationwide• SUGARMDS LLC

Indomethacin Capsules (Glenmark) – Labeling Mix-Up (2023)

Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen

Class IIModerate

FDANov 7, 2023Nationwide• Glenmark Pharmaceuticals Inc., USA

Naproxen Tablets (Glenmark) – Labeling Mix-Up (2023)

Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen

Class IIModerate

FDANov 7, 2023Nationwide• Glenmark Pharmaceuticals Inc., USA

Paroxetine Tablets 40mg (Apotex) – Impurity Specification (2023)

Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine

Class IIModerate

FDANov 1, 2023Nationwide• Apotex Corp.

Paroxetine Tablets 20mg (Apotex) – Impurity Specification (2023)

Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine

Class IIModerate

FDANov 1, 2023Nationwide• Apotex Corp.

Paroxetine Tablets 10mg (Apotex) – Impurity Specification (2023)

Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine

Class IIModerate

FDANov 1, 2023Nationwide• Apotex Corp.

Trospium Chloride Capsules (Padagis) – Capsule Defects (2023)

Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules

Class IIModerate

FDANov 1, 2023Nationwide• Padagis US LLC

Paroxetine Tablets 30mg (Apotex) – Impurity Specification (2023)

Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine

Class IIModerate

FDANov 1, 2023Nationwide• Apotex Corp.

Ranolazine Tablets 500mg (Glenmark) – failed dissolution (2023)

Failed Dissolution Specifications: Out of specification for dissolution.

Class IIModerate

FDAOct 23, 2023Nationwide• Glenmark Pharmaceuticals Inc., USA

Deferasirox Oral Suspension (Glenmark) – failed dissolution (2023)

Failed Dissolution Specifications

Class IIModerate

FDAOct 20, 2023Nationwide• Glenmark Pharmaceuticals Inc., USA

Oxaydo Tablets (Zyla Life Sciences) – Sub-potent Drug (2023)

Sub-potent Drug: Lower potency than labeled.

FDAOct 20, 2023Nationwide• Zyla Life Sciences US Inc.

ELCYS Injection (Exela Pharma) – Particulate Contamination (2023)

Presence of Particulate Matter: Silicone

FDAOct 18, 2023Nationwide• Exela Pharma Sciences LLC

Sodium Bicarbonate Injection (Exela Pharma) – Particulate Issue (2023)

Presence of Particulate Matter: Silicone

FDAOct 18, 2023Nationwide• Exela Pharma Sciences LLC

Midazolam Injection (Exela Pharma) – Particulate Problem (2023)

Presence of Particulate Matter: Silicone

FDAOct 18, 2023Nationwide• Exela Pharma Sciences LLC

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