FDAFDA · Food and drugs·Recall number D-0374-2024
Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15
Published March 20, 2024 · Recall initiated: March 5, 2024
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- BETIMOL
- Manufacturer
- Thea Pharma, Inc.
- Distributor
- Product was distributed nationwide within the United States
- UPC
- 0382584002053
- Lot
- Lot #: 435019, Exp. Date 11/2024
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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