REGULATORY INTELLIGENCE·Recall
Hikma Pharmaceuticals Initiates Nationwide Class II Recall of Alendronate Sodium Oral Solution Due to OOS Assay Results
Hikma Pharmaceuticals USA Inc. has initiated a Class II nationwide recall of Alendronate Sodium Oral Solution (ANDA090520) due to out-of-specification assay results in bottles stored on their side. This event underscores critical supply chain and quality control challenges for procurement directors and regulatory affairs heads, necessitating immediate review of inventory and supplier qualification protocols to mitigate disruption and ensure patient safety.
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