March 2024 FDA Recall Betimol by Thea Pharma, Inc.
D-0374-2024 - Lack of Assurance of Sterility

This Class II drug recall was voluntarily initiated by Thea Pharma, Inc. on March 5, 2024 for the product Betimol. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0374-2024

Reason for Recall
Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.
Initiated
03-05-2024
Reported
03-20-2024
Quantity
5,476 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
94146
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Thea Pharma, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-30-2025
Product Description About Product Description
Full technical description of the product.
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

82584-001-05 Betimol
82584-002-05 Betimol
82584-002-15 Betimol