Betimol recall: Sterility Concern
Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15
Why was Betimol recalled?
Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 435019, Exp. Date 11/2024
- Product
- Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15
- Recalling firm
- Thea Pharma, Inc.
- Quantity
- 5,476 bottles
- Distribution
- Product was distributed nationwide within the United States
- Recall date
- March 20, 2024
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)