Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.
Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15
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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