Imprimis NJOF Recalls Tri-Moxi+ Intraocular Injections Nationwide Due to Glass Particulate Contamination
Imprimis NJOF, LLC initiated a Class II nationwide recall of 6,280 Tri-Moxi+ intraocular injection syringes due to glass-like particulate matter. This event underscores critical quality control vulnerabilities for procurement directors and regulatory affairs heads. Businesses must assess supply chain risks for ophthalmic products, diversify sourcing, and enhance supplier qualification to mitigate future disruptions from similar contamination issues.
FDA Class II Recall: Particulate Matter in Imprimis NJOF's Intraocular Injection
Imprimis NJOF, LLC has initiated a Class II voluntary recall across the U.S. for its Tri-Moxi+ (Triamcinolone 9mg/0.6mL, Moxifloxacin 0.6 mg/ 0.6 mL) Single-Use Intraocular Injection. This critical regulatory action, initiated on December 18, 2025, and reported on January 14, 2026, stems from the confirmed presence of particulate matter, specifically glass-like particles, within the product. The recall impacts 314 boxes, totaling 6,280 pre-filled syringes, from specific lots: 25JAN033A and 25JAN033B, with an expiry date of February 12, 2026. For procurement directors, this means an immediate assessment of inventory and supply lines for this crucial ophthalmic product. The presence of glass-like particles in an intraocular injection poses a significant risk of severe adverse health consequences, including ocular damage, inflammation, or infection, directly impacting patient safety and potentially leading to costly litigation and reputational damage for healthcare providers and distributors. Regulatory affairs heads must ensure all affected product is identified and quarantined, adhering strictly to FDA guidelines for Class II recalls.
Imprimis NJOF Facility Profile and Product Impact
Imprimis NJOF, LLC, located at 1705 Route 46 Ste 6B, Ledgewood, NJ 07852, United States, is the manufacturer responsible for the recalled Tri-Moxi+ intraocular injection. This facility's role in supplying sterile ophthalmic formulations is critical, particularly for products combining anti-inflammatory (Triamcinolone) and antibiotic (Moxifloxacin) agents used in ocular surgery and treatment. The affected product, identified by NDC 71384-746-06, is designed for single-use, emphasizing the need for absolute sterility and freedom from particulates. For business development executives, this recall highlights the inherent risks associated with manufacturing sterile injectable products. Any quality lapse at a production facility, even a voluntary recall, can severely impact market confidence and future contracts. Supply chain VPs must recognize that issues at a single facility can disrupt nationwide distribution, necessitating robust contingency plans and rigorous supplier qualification processes that extend beyond initial audits to continuous monitoring of manufacturing practices and quality control systems.
Supply Chain Exposure for Intraocular Injections
The nationwide distribution pattern of the recalled Tri-Moxi+ intraocular injection means that healthcare systems, pharmacies, and ophthalmic clinics across the entire U.S. are potentially exposed to this supply disruption. Intraocular injections are specialized products, often used in time-sensitive surgical procedures or for chronic conditions, making their availability critical. Procurement teams relying on Imprimis NJOF for this specific combination product will face immediate challenges in securing alternative supplies. The limited shelf life of the affected lots, expiring on February 12, 2026, further compresses the timeline for managing this recall and finding replacements. For supply chain VPs, this event underscores the vulnerability of specialized pharmaceutical supply chains to quality control failures. It necessitates a comprehensive review of all single-source or limited-source critical drug products, especially those requiring high sterility standards. Identifying where this product is integrated into surgical kits or treatment protocols is crucial for mitigating downstream impacts and ensuring patient care continuity.
Sourcing Alternatives for Triamcinolone/Moxifloxacin Formulations
Given the recall of Imprimis NJOF's Tri-Moxi+ intraocular injection, procurement directors must immediately explore alternative suppliers for Triamcinolone and Moxifloxacin injectable formulations. While specific alternative suppliers for this exact combination product are not detailed in the available intelligence, the market for ophthalmic pharmaceuticals typically includes several specialized manufacturers. The challenge lies in qualifying new suppliers, which can be a lengthy process involving rigorous audits, stability studies, and regulatory approvals, often taking 6-12 months or more. Business development executives should view this as an opportunity to assess competitive landscapes and identify potential partners or acquisition targets that possess robust sterile manufacturing capabilities. For regulatory affairs heads, ensuring any alternative product meets the stringent quality and safety standards for intraocular use, including particulate matter limits, is paramount. Diversifying the supplier base, even for individual active pharmaceutical ingredients (APIs) or excipients used in such formulations, is a critical strategy to build resilience against future disruptions.
Industry-Wide Quality Control Challenges and Regulatory Scrutiny
This recall by Imprimis NJOF, LLC for particulate matter in an injectable product is not an isolated incident but reflects broader industry challenges in maintaining stringent quality control for sterile pharmaceuticals. Recent parallel events highlight a recurring pattern of regulatory issues: Essential Wellness Pharma faced a Class II recall for Progesterone Injection due to sterility assurance failures in June 2026, and Spectra Medical Devices encountered a Class II recall for Lidocaine HCl Injection, also due to sterility deficiencies, in June 2026. Furthermore, Guardian Drug Co. Inc. initiated nationwide Class II recalls for Calcium Carbonate Antacids and HyVee Antacid in June 2026 due to metallic contamination. For regulatory affairs heads, this trend signals increased FDA scrutiny on manufacturing processes, particularly for injectables and oral solids where contamination poses direct patient risks. Procurement directors must interpret these events as a clear directive to elevate supplier auditing protocols, focusing on sterility assurance, particulate control, and overall Good Manufacturing Practices (GMP) compliance across their entire vendor portfolio, not just for high-risk products.
Immediate Actions and Future Regulatory Scrutiny
In response to this Class II recall, Imprimis NJOF, LLC is expected to conduct a thorough investigation into the root cause of the glass-like particulate matter and implement comprehensive corrective and preventive actions (CAPA). For supply chain VPs, understanding the manufacturer's remediation plan is crucial for evaluating future supply reliability. The FDA will closely monitor these actions, and failure to adequately address the underlying quality system deficiencies could lead to further regulatory actions, including potential Warning Letters, facility inspections, or even an Import Alert if the facility were to supply internationally. Business development executives should anticipate heightened due diligence requirements for any partnerships involving sterile manufacturing. Regulatory affairs teams must ensure that all internal and external stakeholders are fully informed and that the firm's response aligns with FDA expectations. Proactive engagement with the FDA and transparent communication regarding remediation efforts are vital to restoring confidence and minimizing long-term commercial impact following such a significant product recall.