Why it was recalled
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
Lot numbers, UPCs & expiration codes
Lot #: 435019, Exp. Date 11/2024
Where it was sold
Product was distributed nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0374-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 5, 2024
- FDA report date
- Mar 20, 2024
- Quantity
- 5,476 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Thea Pharma, Inc.
Original FDA data
Every field from FDA enforcement report D-0374-2024, exactly as published.
Show all FDA fields
- City
- Waltham
- State
- MA
- Status
- Terminated
- Country
- United States
- Event ID
- 94146
- Address
- 303 Wyman St
- Code information
- Lot #: 435019, Exp. Date 11/2024
- Postal code
- 02451-1208
- Report date
- Mar 20, 2024
- Product type
- Drugs
- Recall number
- D-0374-2024
- Classification
- Class II
- Recalling firm
- Thea Pharma, Inc.
- Product quantity
- 5,476 bottles
- Termination date
- Jun 30, 2025
- Reason for recall
- Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Recall initiation date
- Mar 5, 2024
- Initial firm notification
- Letter
- Center classification date
- Mar 11, 2024