Rising Pharmaceuticals, Inc. recalls Timolol Maleate USP, 0.5%, 5 mL, Sterile Opthalmic Solution, Rx Only, For Topical Application in the Eye, Distributed b…

Recall date

November 15, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1367-2020

FDA classification

Class III

Brand / firm

Rising Pharmaceuticals, Inc.

Sold / distributed

U.S.A. Nationwide

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Timolol Maleate USP, 0.5%, 5 mL, Sterile Opthalmic Solution, Rx Only, For Topical Application in the Eye, Distributed by: Rising Pharmaceuticals, Inc. Saddle Brook, NJ 07663, Manufactured by: FDC Limited B-8, MIDC Industrial Area, Waluj, Aurangbad - 431 136 Marahastra, India, NDC 64980-514-05