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Showing 641–660 of 1639 results

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Refresh P.M. Eye Ointment (AbbVie) – Tube Seal Breach (2024)

Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.

Class IIModerate

FDASep 16, 2024Nationwide• AbbVie Inc.

Refresh LACRI-LUBE (AbbVie) – Tube Seal Breach (2024)

Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.

Class IIModerate

FDASep 16, 2024Nationwide• AbbVie Inc.

First Aid Antiseptic Ointment (Zhejiang Jingwei) – Incorrect Ingredients (2024)

Undeclared Allergen

Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ". The inactive ingredients in the actual product are polyethylene glycol 400 , polyethylene glycol 4000.

Class IIModerate

FDASep 11, 2024Nationwide• Zhejiang Jingwei Pharmaceutical Co., Ltd.

Mycophenolic Acid Tablets (Ascend) – Dissolution Failure (2024)

Failed Dissolution Specifications

Class IIModerate

FDASep 3, 2024Nationwide• Ascend Laboratories, LLC

AcetaZOLAMIDE Tablets (Rubicon) – Discoloration (2024)

Discoloration

FDAAug 24, 2024Nationwide• Rubicon Research Private Limited

Semaglutide Multiple Dose Vial (ProRx LLC) – Sterility Concern (2024)

Lack of Assurance of Sterility

Class IIModerate

FDAAug 22, 2024Nationwide• ProRx LLC

Tirzepatide Injection (ProRx) – Sterility Concern (2024)

Lack of Assurance of Sterility

Class IIModerate

FDAAug 22, 2024Nationwide• ProRx LLC

Tirzepatide Injection (ProRx) – Sterility Concern (2024)

Lack of Assurance of Sterility

Class IIModerate

FDAAug 22, 2024Nationwide• ProRx LLC

Semaglutide Injection (ProRx) – Sterility Concern (2024)

Lack of Assurance of Sterility

Class IIModerate

FDAAug 22, 2024Nationwide• ProRx LLC

Semaglutide Injection (ProRx) – Sterility Concern (2024)

Lack of Assurance of Sterility

Class IIModerate

FDAAug 22, 2024Nationwide• ProRx LLC

Tirzepatide Multidose (ProRx) – Sterility Concern (2024)

Lack of Assurance of Sterility

Class IIModerate

FDAAug 22, 2024Nationwide• ProRx LLC

Semaglutide/Cyanocobalamin (ProRx) – Sterility Concern (2024)

Lack of Assurance of Sterility

Class IIModerate

FDAAug 22, 2024Nationwide• ProRx LLC

Lidocaine HCl Injection (Fagron) – Sterility Concern (2024)

Lack of Assurance of Sterility

Class IIModerate

FDAAug 15, 2024Nationwide• Fagron Compounding Services

Timolol Maleate Eye Solution (FDC Limited) – Defective Container (2024)

Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.

Class IIModerate

FDAAug 12, 2024Nationwide• FDC Limited

Ibuprofen Tablets (Direct Rx) – Impurity Specification Failure (2024)

Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.

Class IIModerate

FDAAug 9, 2024Nationwide• Direct Rx

Testosterone Gel (Teva) – Superpotent Medication (2024)

Superpotent Drug

Class IIModerate

FDAAug 8, 2024Nationwide• Teva Pharmaceuticals USA, Inc

Ibuprofen Tablets (Preferred Pharmaceuticals) – Impurity Issues (2024)

Failed Impurities/Degradation Specifications - at 18-month Stability testing

Class IIModerate

FDAAug 8, 2024CA, NV• Preferred Pharmaceuticals, Inc.

Ibuprofen 400mg Tablets (Dr. Reddy's) – Impurity Limit Exceeded (2024)

Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.

Class IIModerate

FDAAug 6, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

Ibuprofen 800mg Tablets (Dr. Reddy's) – Impurity Limit Exceeded (2024)

Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.

Class IIModerate

FDAAug 6, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

Ibuprofen 600mg Tablets (Dr. Reddy's) – Impurity Limit Exceeded (2024)

Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.

Class IIModerate

FDAAug 6, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

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