FDA-Drug2024-03-20Class II

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

Thea Pharma, Inc.
Hazard

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

Sold states
Product was distributed nationwide within the United States
Affected count
5,476 bottles
Manufactured in
303 Wyman St, N/A, Waltham, MA, United States
Products
Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15

Official notice

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

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