PlainRecalls
FDA Drug Moderate Class II Terminated

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).

Reported: June 14, 2023 Initiated: May 25, 2023 #D-0867-2023

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.

Details

Units Affected
1,920 bottles
Distribution
Nationwide in the USA
Location
Camarillo, CA

Frequently Asked Questions

What product was recalled?
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).. Recalled by Golden State Medical Supply Inc.. Units affected: 1,920 bottles.
Why was this product recalled?
Lack of Assurance of Sterility: Tamper Evidence Seal is missing on secondary container.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 14, 2023. Severity: Moderate. Recall number: D-0867-2023.