Company: HROW
Filing Date: 2025-08-11
Form Type: 10-Q
Source: 0001641172-25-022980
Chunk: 104

Company: HARROW, INC.
Filing Date: 2025-08-11
Form: 10-Q
Item: Item 4
Chunk 104
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 also may impair our business operations.

Below
we provide in supplemental form the material changes to our risk factors that occurred during the past quarter. Our risk factors disclosed
in Part I, Item 1A, of our Annual Report on Form 10-K for the year ended December 31, 2024, provide additional disclosure for these supplemental
risks and are incorporated herein by reference.

The
federal government could pursue enforcement actions against us to the extent we are unable to demonstrate compliance with cGMPs and other
required regulations, the effects of which could be costly to us and could result in adverse consequences to our business.

In August
2017, the FDA issued 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