FDA recall D-1160-2023

AMMAN PHARMACEUTICAL INDUSTRIES · Class II · drug

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.

Reason for recall

Lack of Assurance of Sterility

Distribution

Product was distributed to two (2) direct accounts in RI and CO.

Key facts

Status: Ongoing
Initiation date: 2023-09-01
Report date: 2023-09-27
Voluntary/Mandated: Voluntary: Firm initiated
Location: Amman, Jordan

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1160-2023