Thea Pharma, Inc.: Drug Recall
Recall #D-0374-2024 · 03/05/2024
Class II: Risk
Recall Details
- Recall Number
- D-0374-2024
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Thea Pharma, Inc.
- Status
- Terminated
- Date Initiated
- 03/05/2024
- Location
- Waltham, MA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,476 bottles
Reason for Recall
Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.
Product Description
Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15
Distribution Pattern
Product was distributed nationwide within the United States
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.