Major Lubrifresh Pm
FDA Recall NDC 0904-6488
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.
The FDA has identified 1 recorded enforcement report(s) associated with Major Lubrifresh Pm (NDC 0904-6488). A significant event, classified as Class II, was initiated on Sep 01, 2023 by Major Pharmaceuticals. The reported reason for this action was: "Lack of Assurance of Sterility"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Lack of Assurance of Sterility
Sep 01, 2023
Sep 27, 2023
282,564 units
Recall Profile & Regulatory Data
Event ID
92974
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
AMMAN PHARMACEUTICAL INDUSTRIES
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to two (2) direct accounts in RI and CO.
Product Description
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.
Batch or Lot Expiration Information
Lot# 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
Affected Packages Involved in this Recall
0904-6488-38Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
