FDAFDA · Food and drugs·Recall number D-1160-2023
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.
Published September 27, 2023 · Recall initiated: September 1, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- AMMAN PHARMACEUTICAL INDUSTRIES
- Distributor
- Product was distributed to two (2) direct accounts in RI and CO.
- 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;
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- Jordan
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