Class III
Terminated
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
- Company
- Rising Pharmaceuticals, Inc.
- Recall Initiated
- November 15, 2019
- Posted
- July 1, 2020
- Recall Number
- D-1367-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Firm Location
- Saddle Brook, NJ, United States
Reason for Recall
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.
Distribution
U.S.A. Nationwide
Lot / Code Info
Lot # 089A016, Exp 12/31/2020
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