FDA-Drug2020-07-01Class III
Timolol Maleate Sterile Opthalmic Solution,USP 0.25%, 5 mL, Rx Only, For Topical Application, Distributed by: Rising Pharmaceuticals, Inc. Saddle Brook, NJ 07863, Manufactured by: FDC Limited B-8, MDC Industrial Area, Waluj, Aurangabad - 431-136 Maharashtra, India, NDC 64980-513-05
Rising Pharmaceuticals, Inc.
Hazard
Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for Timolol Maleate Sterile Ophthalmic solution USP 0.5%, 5ml but the bottle inside was Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml.
Sold states
U.S.A. Nationwide
Affected count
15,072 bottles
Manufactured in
250 Pehle Ave Ste 601, N/A, Saddle Brook, NJ, United States
Products
Timolol Maleate Sterile Opthalmic Solution,USP 0.25%, 5 mL, Rx Only, For Topical Application, Distributed by: Rising Pharmaceuticals, Inc. Saddle Brook, NJ 07863, Manufactured by: FDC Limited B-8, MDC Industrial Area, Waluj, Aurangabad - 431-136 Maharashtra, India, NDC 64980-513-05
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1368-2020Don't want to check this manually?
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