Pharmacy Learning NetworkDorzolamide and Timolol Ophthalmic Solution Recalled Due to Defective Containers

📋 Regulatory Action / Label Change

Micro Labs USA initiated a voluntary recall of dorzolamide and timolol maleate ophthalmic solution 10 mL after receiving complaints involving broken cap spikes and undeliverable drops. The recall affects Lot DLHU0031 with an expiration date of June 2027. The FDA designated the action as a Class II recall, indicating the product may cause temporary or medically reversible adverse health consequences while the likelihood of serious harm remains low.

Professional Impact

• The recall is limited to Lot DLHU0031, expiring June 2027.
• Reported defects include broken cap spikes and inability to dispense drops, potentially disrupting therapy.
• Dorzolamide-timolol is commonly prescribed for glaucoma and ocular hypertension.
• The concern involves container performance and product delivery, not reported efficacy or formulation issues.
• Treatment interruptions could affect patients requiring ongoing intraocular pressure management.

Action Items

• Verify lot numbers for patients currently using dorzolamide-timolol ophthalmic solution.
• Remove affected inventory from dispensing areas and clinic stock.
• Coordinate replacement therapy when affected product is identified.
• Monitor FDA communications for additional recall updates or expanded actions.