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Cefazolin Injection (Sandoz) – Labeling Mix-Up (2025)

Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials contained Cefozalin

Class IHigh

FDAJun 27, 2025Nationwide• Sandoz Inc

Penicillin G Potassium (Sandoz) – Labeling Mix-Up (2025)

Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million Unit

Class IHigh

FDAJun 27, 2025Nationwide• Sandoz Inc

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Cefazolin Injection (Sandoz) – Labeling Mix-Up (2025)

Penicillin G Potassium (Sandoz) – Labeling Mix-Up (2025)

Pitavastatin Tablets 1mg (AvKARE) – Impurity Specification Failure (2025)

Pitavastatin Tablets 2mg (AvKARE) – Impurity Specification Failure (2025)

Lithium Orotate Capsules (GMP Laboratories) – Manufacturing Specification (2025)

Lithium Orotate Capsules (GMP Laboratories) – Manufacturing Specification (2025)

Metoprolol Succinate Tablets 25mg (Granules) – Dissolution Specification Failure (2025)

Levothyroxine Sodium Tablets 100mcg (Accord) – Subpotent Drug (2025)

Levothyroxine Sodium Tablets 50mcg (Accord) – Subpotent Drug (2025)

Lisinopril/Hydrochlorothiazide Tablets (Lupin) – Product Mix-Up (2025)

Levothyroxine Sodium Tablets 150mcg (Accord) – Subpotent Drug (2025)

Levothyroxine Sodium Tablets 175mcg (Accord) – Subpotent Drug (2025)

Levothyroxine Sodium Tablets 112mcg (Accord) – Subpotent Drug (2025)

Levothyroxine Sodium Tablets 25mcg (Accord) – Subpotent Drug (2025)

Levothyroxine Sodium Tablets 25mcg (Accord) – Subpotent Drug (2025)

Gabapentin Capsules 100mg (Harvard Drug) – Defective Container (2025)

Gabapentin Capsules 100mg (Harvard Drug) – Defective Container (2025)

Testosterone Pellet (Qualgen) – Incorrect Label Printing (2025)

Sodium Chloride Injection (B Braun) – Sterility Compromise (2025)

Lisdexamfetamine Capsules 60mg (Sun Pharma) – Dissolution Failure (2025)