← FDA ENFORCEMENT
D-0374-2024Class II

Thea Pharma, Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

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 Monitoring
Reason 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. 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. Open the enforcement explorer →