REGULATORY INTELLIGENCE·Recall
FDA Class III Recall of Fresenius Kabi's Famotidine Injection Highlights Critical Cold Chain Gaps
Fresenius Kabi USA, LLC's Famotidine Injection faced a Class III FDA recall due to temperature abuse during distribution, impacting a single lot. This event underscores the critical need for robust cold chain management and rigorous oversight of logistics partners. Procurement and supply chain leaders must enhance audit protocols to safeguard product integrity and patient safety.
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