D-0867-2023 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 14, 2023
- Initiation Date
- May 25, 2023
- Termination Date
- August 8, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,920 bottles
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).
Reason for Recall
Lack of Assurance of Sterility: Tamper Evidence Seal is missing on secondary container.
Distribution Pattern
Nationwide in the USA
Code Information
Lot #s: a) GS049666, GS049807, Exp: 03/31/2024; b) GS049667, GS051447, Exp: 09/30/2024.