REGULATORY INTELLIGENCE·Recall
FDA Class II Recall: Rubicon Research's Tramadol Contamination Raises Supply Chain Concerns
Rubicon Research Private Limited has initiated a Class II recall for Tramadol Hydrochloride Tablets due to baclofen contamination. This event, impacting 2,592 bottles distributed by Advagen Pharma Limited nationwide, signals critical quality control failures at the Ambarnath, India facility. Procurement and supply chain leaders must immediately assess exposure, diversify sourcing, and enhance supplier due diligence to mitigate disruption and patient safety risks.
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