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Vancomycin

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Antibiotics

CAS1404-90-6HSN29419090
THERAPEUTIC AREAS
MOLECULE INTELLIGENCE SNAPSHOTlive
19
Manufacturers monitored
2
Intelligence briefs
2
Active regulatory actions
1
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INTELLIGENCE

Showing 2 of 2 briefs for Vancomycin
REGULATORY INTELLIGENCE·Recall

FDA Class I Recall: Leiters Health's Superpotent Vancomycin HCl Poses Critical Supply Chain Risk

Leiters Health has initiated a Class I recall of 7,548 IV bags of VANCOmycin HCl PF 1.5g due to a superpotent drug issue from a malfunctioning semi-automated filling system. This FDA action, D-0282-2024, signals a critical manufacturing quality control failure, demanding immediate attention from procurement and regulatory teams to mitigate supply chain disruption and patient safety risks.

90-Day Activity
CMCatherine Morrow· Senior Regulatory Intelligence Analyst
2024-02-07 Recall
REGULATORY INTELLIGENCE·Recall

FDA Class I Recall: Leiters Health's Superpotent Vancomycin HCl Poses Significant Supply Chain Risk

Leiters Health has initiated a Class I recall (D-0281-2024) for 10,152 IV bags of VANCOmycin HCl PF 1.25g due to a semi-automated filling system malfunction causing double doses. This superpotent drug risk from their Englewood, CO facility demands immediate action from procurement and regulatory teams to mitigate patient safety concerns and secure alternative supplies for this critical antibiotic.

90-Day Activity
MKMeera Krishnan· Senior Regulatory Intelligence Analyst
2024-02-07 Recall