CLASS II ONGOING Drug recall · Reported 27 Sep 2023 · FDA Enforcement Report
Major LubriFresh P.M recalled by Amman Pharmaceutical
Amman Pharmaceutical Industries is recalling Major LubriFresh P.M, distributed in Colorado, Rhode Island. The recall was initiated on 1 Sep 2023 and the FDA has classified it as Class II.
Check your package
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.
Recall details
- Recall number
- D-1160-2023
- FDA event ID
- 92974
- Recalling firm
- Amman Pharmaceutical Industries, Amman
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Sep 2023
- FDA classified
- 15 Sep 2023
- Reported
- 27 Sep 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Eye Drops
Timeline
| 1 Sep 2023 | Recall initiated by company | |
| 15 Sep 2023 | Classified by FDA | +14 days |
| 27 Sep 2023 | Published in enforcement report | +12 days |
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.
Questions about this recall
Is Major LubriFresh P.M recalled?
Yes. Amman Pharmaceutical Industries recalled Major LubriFresh P.M on 1 Sep 2023. The recall is Class II and its status is Ongoing. Recall number D-1160-2023.
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lot: 184001 EXP: 11/24; 184002 EXP: 11/24; 184003 EXP: 11/24; Lot: 184004 EXP: 12/24; Lot: 184005 EXP: 12/24; Lot:184006 EXP:12/24;
Where was it sold?
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.