Recalls / Class II
Class IID-1160-2023
Product
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.
- Brand name
- Major Lubrifresh Pm
- Generic name
- Mineral Oil And White Petrolatum
- Active ingredients
- Mineral Oil, Petrolatum
- Route
- Ophthalmic
- NDC
- 0904-6488
- FDA application
- M018
- Affected lot / code info
- 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;
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- AMMAN PHARMACEUTICAL INDUSTRIES
- Manufacturer
- Major Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Building 108, Street A3, King Abdullah Ii Industrial City, Amman, N/A, Jordan
Distribution
- Quantity
- 282,564 units
- Distribution pattern
- Product was distributed to two (2) direct accounts in RI and CO.
Timeline
- Recall initiated
- 2023-09-01
- FDA classified
- 2023-09-15
- Posted by FDA
- 2023-09-27
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-1160-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.