Home / Recalls / Thea Pharma, Inc. / D-0374-2024

D-0374-2024 Class II Terminated

Recalled by Thea Pharma, Inc. — Waltham, MA

Recall Details

Product Type
Drugs
Report Date
March 20, 2024
Initiation Date
March 5, 2024
Termination Date
June 30, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5,476 bottles

Product Description

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.

Distribution Pattern

Product was distributed nationwide within the United States

Code Information

Lot #: 435019, Exp. Date 11/2024