FDA recall D-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).

Reason for recall

Lack of Assurance of Sterility: Tamper Evidence Seal is missing on secondary container.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2023-05-25

Report date

2023-06-14

Termination date

2025-08-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Camarillo, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0867-2023