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Showing 701–720 of 806 results

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ChlorproMAZINE Tablets 100mg (Glenmark) – CGMP Deviations (2025)

CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.

Class IIModerate

FDAMar 11, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Hydrogen Peroxide Solution (Consumer Product) – Label Mixup (2025)

Labeling; Label Mixup; some bottles have an incorrect back label indicating 91% Isopropyl Alcohol

Class IIModerate

FDAMar 7, 2025VA• Consumer Product Partners, LLC

Levothyroxine Sodium Tablets (Mylan) – Super-Potent Drug (2025)

Super-Potent Drug: Out of specification potency results were obtained.

Class IIModerate

FDAMar 7, 2025Nationwide• Mylan Institutional, Inc.

Cinacalcet Hydrochloride Tablets (Slate Run Pharmaceuticals) – Nitrosamine Impurity (2025)

CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.

Class IIModerate

FDAMar 7, 2025Nationwide• Slate Run Pharmaceuticals

Cinacalcet Hydrochloride Tablets (Slate Run Pharmaceuticals) – Nitrosamine Impurity (2025)

CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.

Class IIModerate

FDAMar 7, 2025Nationwide• Slate Run Pharmaceuticals

Duloxetine D/R (Direct Rx) – Nitrosamine Impurity (2025)

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

Class IIModerate

FDAMar 7, 2025Nationwide• Direct Rx

Sodium Bicarbonate Injection (Exela Pharma) – Sterility Concern (2025)

Lack of Assurance of Sterility

Class IIModerate

FDAMar 7, 2025Nationwide• Exela Pharma Sciences LLC

Sofosbuvir and Velpatasvir (ASEGUA) – Defective Container (2025)

Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.

Class IIModerate

FDAMar 7, 2025Nationwide• ASEGUA THERAPEUTICS LLC

Duloxetine D/R (Direct Rx) – Nitrosamine Impurity (2025)

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

Class IIModerate

FDAMar 7, 2025Nationwide• Direct Rx

Levothyroxine Sodium Tablets (Mylan) – Super-Potent Drug (2025)

Super-Potent Drug: Out of specification potency results were obtained.

Class IIModerate

FDAMar 7, 2025Nationwide• Mylan Institutional, Inc.

Fentanyl Citrate (QuVa Pharma) – Sterility Concern (2025)

Lack of Assurance of Sterility

Class IIModerate

FDAMar 6, 2025Nationwide• QuVa Pharma, Inc.

Fentanyl Citrate (QuVa Pharma) – Sterility Concern (2025)

Lack of Assurance of Sterility

Class IIModerate

FDAMar 6, 2025Nationwide• QuVa Pharma, Inc.

Fentanyl Citrate (QuVa Pharma) – Sterility Concern (2025)

Lack of Assurance of Sterility

Class IIModerate

FDAMar 6, 2025Nationwide• QuVa Pharma, Inc.

Prasugrel Tablets (Golden State Medical) – Dissolution Failure (2025)

Failed Dissolution Specifications

Class IIModerate

FDAMar 5, 2025Nationwide• Golden State Medical Supply Inc.

Effaclar Duo (L'Oreal) – Benzene Levels (2025)

cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an abundance of caution, the firm voluntarily recalled all La Roche-Posay Effaclar Duo Dual Action Acne Treatment lots.

Class IIModerate

FDAMar 5, 2025Nationwide• L'Oreal USA

Effaclar Dermatological System (L'Oreal) – Benzene Levels (2025)

cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an abundance of caution, the firm voluntarily recalled all La Roche-Posay Effaclar Duo Dual Action Acne Treatment lots.

Class IIModerate

FDAMar 5, 2025Nationwide• L'Oreal USA

Testosterone Gel (Strides Pharma) – Benzene Presence (2025)

Presence of foreign substance: Presence of Benzene.

Class IIModerate

FDAMar 5, 2025Nationwide• Strides Pharma, Inc.

Golden Crop Candy (Blooming Import) – undeclared colors (2025)

Undeclared Allergen

Contains undeclared and unallowed colors (Blue 1, Red 40, Acid Red 18)

Class IIModerate

FDAMar 5, 2025DE, MD, MA +5 more• Blooming Import Inc.

Effaclar Duo (L'Oreal) – Benzene Contamination (2025)

Chemical Contamination: This recall has been initiated due to detected trace levels of benzene.

Class IIModerate

FDAMar 5, 2025Nationwide• L'Oreal USA

Golden Crop Candy (Blooming Import) – undeclared colors (2025)

Undeclared Allergen

Contains undeclared and unallowed colors (Blue 1, Red 40, Acid Red 18)

Class IIModerate

FDAMar 5, 2025DE, MD, MA +5 more• Blooming Import Inc.

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