Betimol Solution/ Drops
FDA Recall NDC 82584-002
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Betimol (NDC 82584-002). A significant event, classified as Class II, was initiated on Mar 05, 2024 by Thea Pharma Inc.. The reported reason for this action was: "Lack of Assurance of Sterility: Out of specification for volume and compromised container closure."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.
Mar 05, 2024
Mar 20, 2024
5,476 bottles
Recall Profile & Regulatory Data
Event ID
94146
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Thea Pharma, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed nationwide within the United States
Termination Date
Jun 30, 2025
Product Description
Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15
Batch or Lot Expiration Information
Lot# : 435019, Exp. Date 11/2024
Affected Packages Involved in this Recall
82584-001-05Product
82584-002-05Product
82584-002-15Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
