FDA Drug recall D-0374-2024
Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc
- FDA Drug
- Class II
- terminated
- Published 2024-03-20
On 2024-03-20 the FDA classified a Class II recall of Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc by Thea Pharma, citing lack of Assurance of Sterility: Out of specification for volume and compromised container closure.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0374-2024 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2024-03-05 |
| Published | 2024-03-20 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Thea Pharma |
| Distribution | US |
Product
Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15
Reason
Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.
Identifiers
| ndc | 82584-001-05 |
|---|---|
| ndc | 82584-002-05 |
| ndc | 82584-002-15 |
| code_info | Lot #: 435019, Exp. Date 11/2024 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0374-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.