Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15
Reported: March 20, 2024 Initiated: March 5, 2024 #D-0374-2024
Product Description
Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15
Reason for Recall
Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.
Details
- Recalling Firm
- Thea Pharma, Inc.
- Units Affected
- 5,476 bottles
- Distribution
- Product was distributed nationwide within the United States
- Location
- Waltham, MA
Frequently Asked Questions
What product was recalled? ▼
Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15. Recalled by Thea Pharma, Inc.. Units affected: 5,476 bottles.
Why was this product recalled? ▼
Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 20, 2024. Severity: Moderate. Recall number: D-0374-2024.
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