FDA Recalls Betimol Eye Drops for Sterility and Container Closure Defects
Thea Pharma is recalling Betimol (timolol) ophthalmic solution nationwide for lack of sterility assurance and compromised container closure. The defects could allow contamination of the eye medication.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a prescription ophthalmic medication with potential sterility and container integrity defects. While these defects present a risk of harm to patients, no illnesses or injuries have been reported. Per the rubric, risk-of-harm products without reported injury score as High (3).
Plain-English summary
Thea Pharma, Inc. is recalling Betimol (timolol ophthalmic solution) 0.5% in 15mL bottles nationwide. The recall affects lot 435019 with an expiration date of 11/2024. Approximately 5,476 bottles were distributed within the United States.
The recall was initiated due to a lack of assurance of sterility. The product was found to be out of specification for volume and the container closure was compromised. These defects could affect the sterility and integrity of the medication.
Patients who have this product should not use it without consulting their healthcare provider or pharmacist. Those with lot 435019 should stop using the product and contact their pharmacy or Thea Pharma for further instructions.
The recalled product
- Product
- BETIMOL (TIMOLOL)
- Brand
- BETIMOL
- Manufacturer
- Thea Pharma, Inc.
- Category
- Drug — Ophthalmic Medication
- Affected units
- 5,476
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 435019
- Exp. Date 11/2024
UPCs (1)
- 0382584002053
Distribution
Distributed nationwide across the United States.
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