ChemLifeIntel/Companies/Leiters Health

Leiters Health

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Showing 3 of 3 briefs on Leiters Health

REGULATORY INTELLIGENCE·Recall

Leiters Health Faces Class II Recall for Particulate Matter in Lidocaine/Phenylephrine Vials Amidst Prior Class I Violations

Leiters Health has initiated a Class II recall for 40,890 vials of Lidocaine HCL 1% and PHENYLephrine HCL 1.5% due to glass delamination. This event, originating from their Englewood, CO facility, highlights persistent quality control challenges, following two prior Class I recalls for superpotent Vancomycin HCl. Procurement and regulatory teams must assess immediate supply risks and Leiters' long-term compliance trajectory.

90-Day Activity

Leiters Health

RMRohan Mehta· Senior Supply Chain Intelligence Analyst

2024-03-06 Recall

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

Leiters HealthVancomycin

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

Leiters HealthVancomycin

MKMeera Krishnan· Senior Regulatory Intelligence Analyst

2024-02-07 Recall