Diluent Label: 0480-9263-21. - Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U. S Food and Drug Administration (FDA) inspection at the contract manufacturer.

Source: FDA | Recall date: 05/13/2026

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Affected product: Diluent Label: 0480-9263-21.

Summary: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U. S Food and Drug Administration (FDA) inspection at the contract manufacturer.

Hazard: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U. S Food and Drug Administration (FDA) inspection at the contract manufacturer.

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