Recalls / Class II
Class IID-0374-2024
Product
Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15
- Brand name
- Betimol
- Generic name
- Timolol
- Active ingredient
- Timolol
- Route
- Ophthalmic
- NDCs
- 82584-001, 82584-002
- FDA application
- NDA020439
- Affected lot / code info
- Lot #: 435019, Exp. Date 11/2024
Why it was recalled
Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.
Recalling firm
- Firm
- Thea Pharma, Inc.
- Manufacturer
- Thea Pharma Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 303 Wyman St, N/A, Waltham, Massachusetts 02451-1208
Distribution
- Quantity
- 5,476 bottles
- Distribution pattern
- Product was distributed nationwide within the United States
Timeline
- Recall initiated
- 2024-03-05
- FDA classified
- 2024-03-11
- Posted by FDA
- 2024-03-20
- Terminated
- 2025-06-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0374-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.