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ImprimisRx NJ, a compounding pharmacy in New Jersey, produced sterile drug products under insanitary conditions that violated federal manufacturing standards, including contaminated HEPA filters in ISO 5 aseptic processing areas and facility design flaws that allowed inferior air quality into controlled environments. The facility's deficiencies put patients at risk and resulted in the company recalling subpotent timolol-latanoprost ophthalmic drops in November 2022. The violations rendered the drug products adulterated under federal law, as they were prepared and held under conditions that could contaminate them with filth or render them injurious to health.