FDA recall D-0374-2024

Thea Pharma, Inc. · Class II · drug

Product

Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15

Reason for recall

Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.

Distribution

Product was distributed nationwide within the United States

Key facts

Status
Terminated
Initiation date
2024-03-05
Report date
2024-03-20
Termination date
2025-06-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Waltham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0374-2024