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.
FDA Action: Leiters Health Initiates Class II Recall for Particulate Matter
Leiters Health, operating as Denver Solutions, LLC, has initiated a voluntary, firm-initiated Class II recall (D-0363-2024) impacting 40,890 vials of a critical combination injectable: Lidocaine HCL 1% (10mg/mL) and PHENYLephrine HCL 1.5% (15mg/mL). The recall, initiated on February 20, 2024, stems from the presence of particulate matter, specifically identified as glass delamination, within the single-dose vials. This issue, originating from the glass manufacturer, poses a significant risk of adverse events, including emboli, phlebitis, or allergic reactions, which can be severe or even life-threatening depending on the patient's condition and the location of administration. For procurement directors, this means an immediate assessment of inventory for NDC 71449-090-42 across all distribution channels is imperative to identify and quarantine affected lots. Regulatory affairs heads must ensure rapid compliance with recall procedures and prepare for potential inquiries regarding product safety and supply continuity. The nationwide distribution in the USA amplifies the scope of this supply chain disruption, necessitating swift action to mitigate patient risk and maintain product availability.
Leiters Health's Englewood Facility and Product Portfolio Impacted
The affected products, Lidocaine HCL 1% and PHENYLephrine HCL 1.5% in 1 ml single-dose vials, are manufactured by Leiters Health at their facility located at 13796 Compark Blvd, Englewood, CO 80112-7145, United States. These sterile injectable products are critical in various medical settings, including surgical procedures, ophthalmology, and pain management, where Lidocaine acts as a local anesthetic and Phenylephrine as a vasoconstrictor. The recall encompasses eight distinct lots, including Lot #: 2331104 (Exp: 9-Mar-24), 2331137 (Exp: 3-Mar-24), 2331196 (Exp: 11-Mar-24), 2331264 (Exp: 6-Apr-24), 2331282 (Exp: 18-Apr-24), 2331464 (Exp: 8-May-24), 2331481 (Exp: 16-May-24), and 2331500 (Exp: 20-May-24). Supply chain VPs must recognize that the short expiration windows for some of these lots mean that affected product may still be in active use, necessitating urgent communication with downstream customers. Business development executives should note that issues with container-closure integrity, such as glass delamination, can reflect broader quality system vulnerabilities, impacting confidence in the manufacturer's entire sterile product portfolio.
Supply Chain Exposure: Critical Injectables Impacted Nationwide
The recall of 40,890 vials of Lidocaine HCL 1% and PHENYLephrine HCL 1.5% presents a tangible supply chain exposure for healthcare providers and distributors across the United States. Given the essential nature of these molecules in clinical practice, any disruption, even for a Class II recall, can necessitate rapid sourcing adjustments. Procurement teams must identify all customers and facilities that received these specific lots to ensure proper quarantine and return. The nationwide distribution pattern means that the impact is not geographically isolated, requiring a broad and coordinated response. Furthermore, the root cause—glass delamination from the manufacturer—points to a potential vulnerability in the raw material supply chain for container-closure systems. Supply chain VPs should initiate a review of their supplier qualification processes for all primary packaging materials, especially for sterile injectables, to identify and mitigate similar risks from other manufacturers. This incident underscores the importance of robust incoming material inspection and vendor management programs to prevent compromised components from entering the manufacturing process, thereby safeguarding patient safety and supply continuity.
Leiters Health's Recurring Regulatory Compliance Challenges
This Class II recall for particulate matter is not an isolated incident for Leiters Health, indicating a concerning pattern of regulatory compliance challenges. ChemLifeIntel's intelligence graph reveals that Leiters Health was previously involved in two separate FDA Class I recalls, both published on February 7, 2024, for "Superpotent Vancomycin HCl." Class I recalls are the most serious type, signifying a reasonable probability that product use will cause serious adverse health consequences or death. The recurrence of significant quality issues, transitioning from potency deviations in Vancomycin HCl to particulate matter in Lidocaine/Phenylephrine, suggests systemic deficiencies in Leiters Health's quality management system. For procurement directors, this history elevates the risk profile of Leiters Health as a supplier. It necessitates a thorough re-evaluation of supplier audits, quality agreements, and the potential need for diversification to alternative sources for critical drug products. Regulatory affairs heads must recognize that repeated violations, even of different types, increase the likelihood of escalated FDA enforcement actions, including potential Warning Letters or consent decrees, which could severely impact Leiters' operational capacity and long-term supply reliability.
Future Outlook: Leiters Health Remediation and Enhanced FDA Scrutiny
As the recall for Lidocaine HCL 1% and PHENYLephrine HCL 1.5% remains ongoing, Leiters Health is obligated to conduct a comprehensive root cause analysis for the glass delamination and implement robust corrective and preventive actions (CAPA). This will likely involve scrutinizing their glass vial supplier's manufacturing processes, incoming material quality control, and potentially their own filling and finishing operations. Given the company's recent history of two Class I recalls for superpotent Vancomycin HCl, the FDA is expected to exercise heightened scrutiny over Leiters Health's remediation efforts. Supply chain VPs should anticipate that any delays or inadequacies in Leiters' CAPA plan could lead to further regulatory actions, potentially impacting other products manufactured at their Englewood, CO facility. Business development executives considering partnerships or sourcing agreements with Leiters Health must factor in this elevated regulatory risk, as ongoing compliance issues can translate into significant operational disruptions, reputational damage, and increased costs. Proactive engagement with Leiters Health to understand their remediation strategy and timelines is crucial for mitigating future supply chain vulnerabilities.