Class II

Drug Recall: 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. · March 5, 2024

Reason for Recall

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

Distribution

Product was distributed nationwide within the United States

States Affected

NATIONWIDE

Quantity Affected

5,476 bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0374-2024

Status: terminated

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