CLASS IIONGOINGDrug recall · Reported 27 Sep 2023 · FDA Enforcement Report
Major LubriFresh P.M. Nighttime Ointment recalled
Amman Pharmaceutical Industries is recalling Major LubriFresh P.M. Nighttime Ointment, Lubricant Eye Ointment, Sterile, distributed in Colorado, Rhode Island. The recall was initiated on 1 Sep 2023 and the FDA has classified it as Class II.
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
MAJOR LubriFresh P.M. Nighttime Ointment, Lubricant Eye Ointment, Sterile, 0.125 OZ (3.5g), Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, Made in Jordan, NDC: 0904-6488-38.
Where it was distributed
Product was distributed to two (2) direct accounts in RI and CO.
Product was distributed to two (2) direct accounts in RI and CO.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.