AvKARE Initiates Class II Recall of Cinacalcet Tablets Over Nitrosamine Impurity Concerns
AvKARE has initiated a nationwide Class II recall for 2,396 bottles of Cinacalcet Tablets, 60 mg, due to unacceptable levels of N-Nitroso-Cinacalcet, a nitrosamine impurity. This event highlights critical CGMP deviations and mandates immediate action for procurement and supply chain leaders to assess risk and secure alternative sourcing strategies for this essential drug.
AvKARE's Class II Recall of Cinacalcet Tablets Due to Nitrosamine Impurity
AvKARE, based in Pulaski, Tennessee, has initiated a voluntary, firm-initiated Class II recall for 2,396 bottles of its Cinacalcet Tablets, 60 mg, distributed nationwide across the USA. This critical action, designated recall number D-0109-2025, commenced on November 27, 2024, following the discovery of Current Good Manufacturing Practice (CGMP) deviations. Specifically, the affected product, identified by NDC 42291-460-30 and Lot # 44550 with an expiration date of December 31, 2024, was found to contain N-Nitroso-Cinacalcet, a Nitrosamine Drug Substance Related Impurity (NDSRI), at levels exceeding the acceptable intake limit. For procurement directors and regulatory affairs heads, this means immediate action is required to identify and quarantine any affected inventory. The presence of NDSRIs, known potential human carcinogens, necessitates a thorough review of your quality control protocols and supplier agreements to prevent similar contamination events that can lead to significant market disruptions and reputational damage.
AvKARE's Pulaski Operations and Broader Product Portfolio
AvKARE operates as a manufacturer and distributor from its facility in Pulaski, Tennessee, playing a role in the US pharmaceutical supply chain. The current recall of Cinacalcet Tablets, a medication used to treat hyperparathyroidism, directly involves products manufactured for AvKARE at this location. While the specific FEI number for the Pulaski facility is not disclosed in the immediate recall data, its designation as a formulation site underscores its importance in processing and packaging finished drug products. Business development executives should note that AvKARE's broader product portfolio includes a diverse range of generic medications, such as Pregabalin, Chloroquine Phosphate, Mirtazapine, and Dutasteride, among many others. This extensive range means that quality issues at one facility can have cascading effects across multiple therapeutic areas. Understanding the full scope of a supplier's operations and their historical compliance is crucial for assessing potential supply chain vulnerabilities and ensuring continuity of patient care.
Commercial Impact and Supply Chain Vulnerabilities from AvKARE's Cinacalcet Recall
The nationwide distribution of 2,396 bottles of Cinacalcet Tablets, 60 mg, across the USA implies a significant commercial impact on pharmacies, distributors, and healthcare providers. Supply chain VPs must recognize that a Class II recall, while not immediately life-threatening, indicates a situation where the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences. This event will trigger reverse logistics, inventory write-offs, and potential stockouts for downstream partners. The financial implications extend beyond the recalled product to include potential legal liabilities and erosion of trust. Furthermore, the presence of an NDSRI like N-Nitroso-Cinacalcet highlights a systemic failure in CGMP, which can lead to increased scrutiny from the FDA on all products associated with AvKARE. This necessitates a comprehensive risk assessment of all products sourced from AvKARE to proactively mitigate future supply disruptions and ensure patient safety.
Mitigating Cinacalcet Supply Risk: Strategic Sourcing and Diversification
For procurement teams, this recall underscores the urgent need for robust supplier diversification, particularly for critical molecules like Cinacalcet. While specific alternative suppliers for Cinacalcet are not detailed in the immediate context, companies such as Aurohealth, Granules India, NorthStar Rx, and Apotex represent broader alternative sourcing options for various generic pharmaceuticals. Qualifying new suppliers can involve timelines ranging from 6 to 18 months, depending on the complexity of the molecule and regulatory requirements. Therefore, proactive engagement with potential alternative manufacturers, including those in geographically diverse regions like India (e.g., Granules India) and Canada (e.g., Apotex), is essential. Regulatory affairs heads should prioritize due diligence, including facility audits and comprehensive data reviews, to ensure any new supplier meets stringent quality and compliance standards, thereby safeguarding against future nitrosamine-related recalls and ensuring uninterrupted supply.
AvKARE's Pattern of Regulatory Non-Compliance and Quality Control Failures
This latest Class II recall for Cinacalcet Tablets is not an isolated incident for AvKARE, indicating a concerning pattern of regulatory non-compliance and quality control failures. ChemLifeIntel's historical intelligence reveals several prior recalls initiated by AvKARE. In January 2020, the company faced a medium-severity recall for Dutasteride due to impurity failures, directly mirroring the current nitrosamine issue. This was followed by another medium-severity recall in June 2020 for Lamotrigine, attributed to foreign substance contamination. Most critically, AvKARE was involved in a high-severity Class I recall in December 2020 for a Trazodone-Sildenafil mix-up, which occurred at a third-party facility. This consistent history of quality lapses, ranging from impurities to contamination and product mix-ups, signals a systemic vulnerability in AvKARE's quality management systems or its oversight of contract manufacturers. For regulatory affairs and business development executives, this pattern elevates the risk profile associated with AvKARE as a supplier, demanding heightened scrutiny and potentially necessitating a re-evaluation of existing partnerships.
Immediate Actions and Long-Term Compliance Outlook for AvKARE
The ongoing Class II recall of Cinacalcet Tablets requires AvKARE to implement immediate corrective actions, including notifying affected customers and managing product returns. The FDA's classification indicates that while the health risk is not severe enough for a Class I designation, the CGMP deviations leading to the NDSRI presence are serious and demand thorough investigation. AvKARE must identify the root cause of the N-Nitroso-Cinacalcet contamination, which could stem from raw material sourcing, manufacturing processes, or storage conditions. For supply chain VPs, this means anticipating potential delays in future product releases from AvKARE as they address these issues. The FDA will expect a comprehensive remediation plan, and future inspections of AvKARE's Pulaski facility will likely focus heavily on nitrosamine control and overall CGMP adherence. Failure to adequately address these recurring quality issues could lead to further regulatory enforcement actions, including potential Warning Letters, increased inspection frequency, or even placement on Import Alert for certain products, severely impacting their market access and viability.