MAJOR LubriFresh P recalled over sterility concerns
- Recall date
- September 1, 2023
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- AMMAN PHARMACEUTICAL INDUSTRIES recalls MAJOR LubriFresh P.M. Nighttime Ointment, Lubricant Eye Ointment, Sterile, 0.125 OZ (3.5g), Distributed by: MAJOR PHARM…
- Recall number
- D-1160-2023
- FDA classification
- Class II
- Brand / firm
- AMMAN PHARMACEUTICAL INDUSTRIES
- Sold / distributed
- Product was distributed to two (2) direct accounts in RI and CO.
Why it was recalled
Lack of Assurance of Sterility
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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