Drug 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).
D-0867-2023
Product summary
- Event
- Event 92402
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,920 bottles
- Official record key
drug-enforcement:D-0867-2023
Official wording
Reason: Lack of Assurance of Sterility: Tamper Evidence Seal is missing on secondary container.
Code information: Lot #s: a) GS049666, GS049807, Exp: 03/31/2024; b) GS049667, GS051447, Exp: 09/30/2024.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility