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

FDA recall notice · announced March 20, 2024 · Thea Pharma

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Product was distributed nationwide within the United States
Lot/code information: Lot #: 435019, Exp. Date 11/2024
Quantity: 5,476 bottles
Status: Terminated
Products in this recall event:
- Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15 (D-0374-2024)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.