Recalls / Class II
Class IID-0867-2023
Product
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).
- Brand name
- Travoprost
- Generic name
- Travoprost
- Active ingredient
- Travoprost
- Route
- Ophthalmic
- NDC
- 51407-731
- FDA application
- ANDA203431
- Affected lot / code info
- Lot #s: a) GS049666, GS049807, Exp: 03/31/2024; b) GS049667, GS051447, Exp: 09/30/2024.
Why it was recalled
Lack of Assurance of Sterility: Tamper Evidence Seal is missing on secondary container.
Recalling firm
- Firm
- Golden State Medical Supply Inc.
- Manufacturer
- Golden State Medical Supply, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 5187 Camino Ruiz, Camarillo, California 93012-8601
Distribution
- Quantity
- 1,920 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-05-25
- FDA classified
- 2023-06-06
- Posted by FDA
- 2023-06-14
- Terminated
- 2025-08-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0867-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.