FDA-Drug2023-09-27Class II
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.
AMMAN PHARMACEUTICAL INDUSTRIES
Hazard
Lack of Assurance of Sterility
Sold states
Product was distributed to two (2) direct accounts in RI and CO.
Affected count
282,564 units
Manufactured in
Building 108, Street A3, King Abdullah Ii Industrial City, Amman, Jordan
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1160-2023Don't want to check this manually?
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