Drug Enforcement D-0374-2024

Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.

Status

Terminated

Classification

Class II

Report Date

March 20, 2024

Termination Date

June 30, 2025

Product Information

Product description
Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15
Product quantity
5,476 bottles
Reason for recall
Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Product was distributed nationwide within the United States

Location & Firm

Recalling firm
Thea Pharma, Inc.
Address
303 Wyman St, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0374-2024
Event ID
94146
Recall initiation date
March 5, 2024
Center classification date
March 11, 2024
Code info
Lot #: 435019, Exp. Date 11/2024
More code info
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