Class II · Moderate risk Ongoing
Dorzolamide HCl and Timolol Maleate Ophthalmic Solution
Reason Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
Timolol Maleate USP
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
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.
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
- Recalling firm
- Rising Pharmaceuticals, Inc.
- NDC code
- 64980-514-05
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1367-2020
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Timolol recalls
See all
Class II · Moderate risk Ongoing
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution
Reason Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Class II · Moderate risk Ongoing
Timolol Maleate Ophthalmic Solution USP
Reason Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
Class II · Moderate risk Ongoing
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution
Reason Lack of Assurance of Sterility
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