Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Timolol Maleate Ophthalmic Solution, USP 0.5%, packaged in a) 2.5mL bottles, b) 5mL bottles, c) 10 mL bottles, and d)15mL bottles, Rx only, Manufactured by: Akorn , Inc, Lake Forest, IL 60045. ALL NDCs
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.
Reason Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Reason Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
Reason Lack of Assurance of Sterility
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