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FDARecalled Mar 20, 2024 · #D-0374-2024

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

Hazard

Class II — temporary health risk

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Description

Lack of Assurance of Sterility: Out of specification for volume and compromised container closure. Classification: Class II Distribution: Product was distributed nationwide within the United States

Product details

Product
Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15
Type
Drugs
Manufacturer
Thea Pharma, Inc.
Model numbers
435019
UPCs