Recalling firm
Thea Pharma, Inc.
Product type
Drug
Status
Terminated
Report date
2024-03-20
Distribution
Product was distributed nationwide within the United States
Firm state
MA
Product quantity
5,476 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental MonitoringReason for recall
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
Code / lot info
Lot #: 435019, Exp. Date 11/2024
Other recalls SPEQ maps to Environmental Monitoring
See all Environmental Monitoring recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.