Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15
Recall Number: D-0374-2024
Firm: Thea Pharma, Inc.
Classification: Class II
Status: Terminated
Report Date: 20240320
Initiation Date: 20240305
Termination Date: 20250630
Reason for Recall
Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.
Product Description
Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15