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Showing 1021–1040 of 14370 results

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

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

FDANov 22, 2023Nationwide• Novartis Pharmaceuticals Corporation

Penicillamine Tablets (Lupin) – Dissolution Failure (2023)

Failed Dissolution Specifications

Class IIModerate

FDANov 22, 2023Nationwide• Lupin Pharmaceuticals Inc.

Thiamine/Pyridoxine Injection (AnazaoHealth) – Particulate Matter (2023)

Presence of Particulate Matter.

Class IIModerate

FDANov 22, 2023Nationwide• AnazaoHealth Corporation

ceFAZolin Sodium Injection (Wells Pharma) – Sterility Concern (2023)

Lack of assurance of sterility.

Class IIModerate

FDANov 22, 2023PA• Wells Pharma of Houston LLC

buPROPion Tablets (Sun Pharmaceutical) – Failed Dissolution (2023)

Failed Dissolution Specifications

FDANov 22, 2023Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

B-Complex Injection (AnazaoHealth) – Particulate Matter (2023)

Presence of Particulate Matter.

Class IIModerate

FDANov 22, 2023Nationwide• AnazaoHealth Corporation

TING Athlete's Foot Spray (Insight Pharmaceuticals) – Benzene Contamination (2023)

Chemical Contamination; presence of benzene.

FDANov 22, 2023Nationwide• Insight Pharmaceuticals Corporation

Votrient Tablets (Siegfried Barbera) – Failed Dissolution (2023)

Failed Dissolution Specifications

FDANov 20, 2023Nationwide• Siegfried Barbera, SL

Vigabatrin Oral Solution (InvaGen) – Defective Container (2023)

Defective Container: powder may leak out of the pouch

FDANov 17, 2023Nationwide• InvaGen Pharmaceuticals, Inc.

Ondansetron Injection (Baxter) – Failed pH Specs (2023)

Failed pH Specifications

Class IIModerate

FDANov 14, 2023Nationwide• Baxter Healthcare 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

Testosterone Gel (Teva) – viscosity out of spec (2023)

OOS for viscosity

FDANov 10, 2023Nationwide• Teva Pharmaceuticals USA, Inc

Paroxetine 10mg Tablets (Golden State Medical) – impurity specification (2023)

Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine

Class IIModerate

FDANov 10, 2023Nationwide• Golden State Medical Supply Inc.

Paroxetine 20mg Tablets (Golden State Medical) – impurity specification (2023)

Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine

Class IIModerate

FDANov 10, 2023Nationwide• Golden State Medical Supply Inc.

Paroxetine 40mg Tablets (Golden State Medical) – impurity specification (2023)

Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine

Class IIModerate

FDANov 10, 2023Nationwide• Golden State Medical Supply Inc.

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

Phenylephrine HCl Injection (SCA Pharmaceuticals) – Sterility Concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDANov 9, 2023Nationwide• SCA Pharmaceuticals, LLC

PHENYLephrine HCl Injection (SCA Pharmaceuticals) – Sterility Concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDANov 9, 2023Nationwide• SCA Pharmaceuticals, LLC

Phenylephrine HCl Injection (SCA Pharmaceuticals) – Sterility Concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDANov 9, 2023Nationwide• SCA Pharmaceuticals, LLC

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