ChemLifeIntel/Companies/IntegraDose Compounding Services LLC

IntegraDose Compounding Services LLC

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INTELLIGENCE

Showing 3 of 3 briefs on IntegraDose Compounding Services LLC

REGULATORY INTELLIGENCE·Recall

IntegraDose Compounding Services Faces Second Fentanyl Citrate Recall for Subpotency, Raising Supply Chain Risk

IntegraDose Compounding Services LLC has initiated a nationwide Class II recall for 376 cassettes of subpotent fentaNYL Citrate, Sterile CADD for Injection. This marks the company's second recall for Fentanyl Citrate and its third for subpotency, signaling systemic quality control issues. Procurement and supply chain leaders must immediately assess inventory and diversify sourcing to mitigate significant patient safety and supply disruption risks.

90-Day Activity

IntegraDose Compounding Services LLCFentanyl Citrate

PSPriya Subramaniam· Intelligence Analyst

22d ago▲ Trending signal

REGULATORY INTELLIGENCE·Recall

IntegraDose Fentanyl Citrate Recall: Sterility Failure Poses Critical Supply Chain and Patient Safety Risks

IntegraDose Compounding Services LLC initiated a nationwide Class II recall of 187 cassettes of fentaNYL Citrate 2,500 mcg/50mL in Sterile Water due to leaking bags, indicating a critical lack of sterility assurance. This event mandates immediate action for procurement directors to secure alternative opioid analgesic supplies and for regulatory affairs heads to scrutinize supplier quality systems, mitigating patient safety risks and supply chain disruptions.

90-Day Activity

IntegraDose Compounding Services LLC

PSPriya Subramaniam· Intelligence Analyst

2024-04-10

REGULATORY INTELLIGENCE·Recall

IntegraDose Vasopressin Recall: Sub-Potency Exposes Minnesota Healthcare Providers to Supply Risk and Regulatory Scrutiny

IntegraDose Compounding Services LLC has initiated a Class II recall for 1,299 syringes of Vasopressin due to sub-potency, failing to maintain strength through its expiration date. This event, coupled with a prior Fentanyl Citrate recall, signals systemic quality control issues. Procurement and regulatory teams must assess immediate supply chain risks for compounded drugs in Minnesota and scrutinize IntegraDose's compliance trajectory.

90-Day Activity

IntegraDose Compounding Services LLCVasopressin

CMCatherine Morrow· Senior Regulatory Intelligence Analyst

2024-02-21▲ Trending signal