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Showing 821–840 of 1571 results

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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

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

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

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.

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 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.

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.

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.

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

Failed Dissolution Specifications: Out of specification for dissolution.

Class IIModerate

FDAOct 23, 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.

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

Failed Dissolution Specifications

Class IIModerate

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

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

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

Presence of Particulate Matter: Silicone

FDAOct 18, 2023Nationwide• Exela Pharma Sciences LLC

Synthroid Levothyroxine Tablets (AbbVie) – Incorrect Barcode (2023)

Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that causes a 125mcg unit dose is scanned as 200mcg unit dose.

FDAOct 17, 2023IN, OR• AbbVie Inc.

The Rock Performance Capsules (Noah's Wholesale) – Unauthorized Sildenafil (2023)

Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with Sildenafil an ingredient found in an FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.

FDAOct 16, 2023FL• Noah's Wholesale LLC

Triamcinolone Acetonide Injection (Eugia) – glass particulate matter (2023)

Presence of Particulate Matter: A product complaint of a piece of glass was identified in a vial. The piece of glass appears to be roughly 1 cm x 0.5 cm inside the vial.

Class IIModerate

FDASep 28, 2023Nationwide• Eugia US LLC

Gynazole-1 Vaginal Cream (Padagis) – incorrect product formulation (2023)

Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.

Class IIModerate

FDASep 28, 2023Nationwide• Padagis US LLC

Methotrexate Tablets (West-Ward Columbus) – surface defect (2023)

Failed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two tablets demonstrating illegible tablet identification and scoring.

FDASep 22, 2023MS, OH• West-Ward Columbus Inc

Sandimmune Oral Solution (Novartis) – Crystallization Issue (2023)

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

FDASep 8, 2023Nationwide• Novartis Pharmaceuticals Corp.

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