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Lorazepam Tablets 2mg (Major) – Potency Concern (2025)

Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.

Class II

FDAJan 21, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Lorazepam Tablets 0.5mg (Major) – Potency Concern (2025)

Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.

Class II

FDAJan 21, 2025Nationwide

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Lorazepam Tablets 2mg (Major) – Potency Concern (2025)

Lorazepam Tablets 0.5mg (Major) – Potency Concern (2025)

Phenylephrine Injection (Provepharm) – Particulate Matter (2025)

Inflectra Injection (McKesson) – Distribution Error (2025)

Duloxetine Capsules (Harvard Drug Group) – Nitrosamine Impurity (2025)

Granix Injection (Teva) – Failed Stability Test (2025)