Travoprost Solution
FDA Recall NDC 51407-731
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Travoprost (NDC 51407-731). A significant event, classified as Class II, was initiated on May 25, 2023 by Golden State Medical Supply, Inc.. The reported reason for this action was: "Lack of Assurance of Sterility: Tamper Evidence Seal is missing on secondary container."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Lack of Assurance of Sterility: Tamper Evidence Seal is missing on secondary container.
May 25, 2023
Jun 14, 2023
1,920 bottles
Recall Profile & Regulatory Data
Event ID
92402
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Golden State Medical Supply Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Aug 08, 2025
Product Description
Travoprost Ophthalmic Solution, USP (Ionic Buffered Solution), 0.004%, Rx only, Manufactured by Apotex Inc., Manufactured by: GSMS Incorporated, Camarillo, CA 93012, a) NDC 51407-731-25 (2.5 mL bottle), b) NDC 51407-731-05 (5 mL bottle).
Batch or Lot Expiration Information
Lot# s: a) GS049666, GS049807, Exp: 03/31/2024; b) GS049667, GS051447, Exp: 09/30/2024.
Affected Packages Involved in this Recall
51407-731-25Product
51407-731-05Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
