Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 024
Summary
The FDA issued a Class II for Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured by Thea Pharma, Inc.. Reason: Lack of Assurance of Sterility: Out of specification for volume and compromised container closure..
Details
Source
Drug Recall
External ID
D-0374-2024
Action Date
2024-03-20
Status
Terminated
Category
drug
Product Description
Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15
Lot/Code Info: Lot #: 435019, Exp. Date 11/2024
Quantity Affected: 5,476 bottles
Reason for Recall
Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.
Distribution
Product was distributed nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2024-03-05
Company
Waltham, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 46 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Thea Pharma, Inc. has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Thea Pharma, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Thea Pharma, Inc. have FDA actions?
Thea Pharma, Inc. has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0374-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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