← FDA ENFORCEMENT
D-1160-2023Class II

AMMAN PHARMACEUTICAL INDUSTRIES

Recalling firm
AMMAN PHARMACEUTICAL INDUSTRIES
Product type
Drug
Status
Ongoing
Report date
2023-09-27
Distribution
Product was distributed to two (2) direct accounts in RI and CO.
Product quantity
282,564 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lack of Assurance of Sterility

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.

Code / lot 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;

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See all Environmental Monitoring recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.