Company: HROW
Filing Date: 2025-11-10
Form Type: 10-Q
Source: 0001493152-25-021562
Chunk: 74

Company: HARROW, INC.
Filing Date: 2025-11-10
Form: 10-Q
Item: Item 1
Chunk 74
---
 a MedWatch notification regarding a curcumin emulsion and two adverse events that had been associated with
the use of these emulsions by prescribing physicians. We issued a press release on August 7, 2017, clarifying certain facts regarding
the notice which outlined our belief that the adverse events associated with the two patients occurred due to an allergic reaction caused
by the products being inappropriately administered and obtained by the prescribing physician, and our use of curcumin and excipients
in our curcumin emulsion formulation met regulatory standards required for dispensing of the curcumin emulsion. In September 2017, the
FDA released a letter confirming that the alleged misuse of certain ingredients in our curcumin emulsions was due to mislabeling by the
underlying supplier and not of our own misdoing. We no longer compound curcumin emulsion products. Separately, in December 2017, we were
issued a warning letter from the FDA alleging that, in its interpretation of our public communications, we had made false or misleading
claims and omitted risk and side effect information regarding certain of our ophthalmology-focused compounded medications. We immediately
performed a full review of our public communications referenced in the warning letter and responded to the FDA in January 2018; notwithstanding
our continued belief that our public communications were not, in fact, false and misleading, we remained in communication with the FDA
and took steps to address the items outlined in the FDA letter. The Company received another warning letter from the FDA in June 2022
related to our alleged marketing activities. We immediately responded to the warning letter and the FDA sent the Company notice in January
2023 that our corrective actions appear adequate. In June 2019, our New Jersey-based outsourcing facility (“NJOF”) was issued
a warning letter related to an April 2017 inspection and our use of certain active pharmaceutical ingredients in our compounded medications.
During September 2020 through January 2021, our New Jersey based outsourcing facility was inspected by the FDA (the “2020 Inspection”)
and certain observations were made by the FDA in a Form 483. Five observations made during the 2020 Inspection were considered repeat
observations from a 2017 FDA inspection. In addition, during the 2020 inspection, the FDA noted that we were compounding drugs for which
there is no change that produces a clinical difference for an individual patient, as determined by a prescribing practitioner between
a compounded drug and