FDA-Drug2026-07-08Class II

prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (NDC 70748-332-02); b) 10 mL (NDC 70748-332-03), c) 15 mL (70748-332-04), Manufactured by: Lupin Limited, Pithampur (M.P) 454 775, INDIA

Hazard

Presence of Foreign Substance

Sold states
U.S. Nationwide
Affected count
2,530,182 bottles
Manufactured in
5801 Pelican Bay Blvd Ste 500, N/A, Naples, FL, United States
Products
prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (NDC 70748-332-02); b) 10 mL (NDC 70748-332-03), c) 15 mL (70748-332-04), Manufactured by: Lupin Limited, Pithampur (M.P) 454 775, INDIA

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0655-2026

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