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Showing 1201–1220 of 2326 results

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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

Equate Hand Sanitizer (Omega & Delta) – Potency Issue (2023)

Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.

Class IIModerate

FDAOct 20, 2023IN, PR• Omega & Delta Co., Inc.

DOP Hand Sanitizer Original (Omega & Delta) – Potency Problem (2023)

Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.

Class IIModerate

FDAOct 20, 2023IN, PR• Omega & Delta Co., Inc.

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

Failed Dissolution Specifications

Class IIModerate

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

DOP Hand Sanitizer (Omega & Delta) – Potency Concern (2023)

Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.

Class IIModerate

FDAOct 20, 2023IN, PR• Omega & Delta Co., Inc.

OTC Drug Products (Dollar Tree) – Temperature Storage Violation (2023)

CGMP Deviations: OTC products were stored outside of labeled temperature requirements.

Class IIModerate

FDAOct 5, 2023Nationwide• Dollar Tree Distribution, Inc.

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

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

TRP Natural Eyes Dryness Relief PF (Amman Pharmaceuticals) – sterility concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDASep 1, 2023CO, IN, RI• AMMAN PHARMACEUTICAL INDUSTRIES

TRP Natural Eyes Red Eye Relief (Amman Pharmaceuticals) – sterility concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDASep 1, 2023CO, IN, RI• AMMAN PHARMACEUTICAL INDUSTRIES

Octiq Lubricating Eye Drops (Amman Pharmaceuticals) – sterility concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDASep 1, 2023CO, IN, RI• AMMAN PHARMACEUTICAL INDUSTRIES

TRP Natural Eyes Blur Relief (Amman) – Sterility Concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDASep 1, 2023CO, IN, RI• AMMAN PHARMACEUTICAL INDUSTRIES

TRP Natural Eyes Eye Lid Relief (Amman Pharmaceuticals) – sterility concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDASep 1, 2023CO, IN, RI• AMMAN PHARMACEUTICAL INDUSTRIES

TRP Natural Eyes Twitching Relief (Amman Pharmaceuticals) – sterility concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDASep 1, 2023CO, IN, RI• AMMAN PHARMACEUTICAL INDUSTRIES

TRP Natural Eyes Pink Eye Relief PF (Amman Pharmaceuticals) – sterility concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDASep 1, 2023CO, IN, RI• AMMAN PHARMACEUTICAL INDUSTRIES

TRP Natural Eyes Red Eye Relief (Amman Pharmaceuticals) – sterility concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDASep 1, 2023CO, IN, RI• AMMAN PHARMACEUTICAL INDUSTRIES

LubriFresh PM Nighttime Eye Ointment (Amman Pharmaceuticals) – sterility concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDASep 1, 2023CO, IN, RI• AMMAN PHARMACEUTICAL INDUSTRIES

TRP Natural Eyes Stye Relief (Amman Pharmaceuticals) – sterility concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDASep 1, 2023CO, IN, RI• AMMAN PHARMACEUTICAL INDUSTRIES

TRP Natural Eyes Floaters Relief (Amman Pharmaceuticals) – sterility concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDASep 1, 2023CO, IN, RI• AMMAN PHARMACEUTICAL INDUSTRIES

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