Golden State Medical Supply, Inc. Issues a Voluntary Nationwide Recall of Travoprost Ophthalmic Solution 0.004% Due to Absence of Tamper-Evident Seals.
Doug Blackburn, Vice President of Quality and Compliance
(800) 284-8633, ext. 116
FOR IMMEDIATE RELEASE – May 25, 2023, Golden State Medical Supply, Incorporated (GSMS, Inc.) – Camarillo, CA has initiated a voluntary consumer level recall of specific lots of Travoprost Ophthalmic Solution 0.004% 2.5mL and 5mL due to a missing tamper-evident seal on the product carton.
This voluntary recall only affects the product lots listed in the table below.
Travoprost Ophthalmic Solution (ionic buffered solution) 0.004% is a sterile solution indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. It’s required that the product be filled and closed in a sterile container and be packaged in a carton with a tamper-evident seal.
While the product carton provides the following instructions: “TAMPER EVIDENT: DO NOT USE IF SEAL ON CARTON IS BROKEN OR MISSING”, product integrity cannot be assured, so this recall is being taken out of an abundance of caution despite the instructions on the carton.
In rare and extreme situations, if tampering were to occur and went undetected, patients may be exposed to hazards associated with the use of contaminated sterile ophthalmic solutions from minor eye irritation and inflammation, up to bacterial infection.
For more drug label information about Travoprost Ophthalmic Solution visit:
DailyMed – Travoprost Ophthalmic Solution (nih.gov)
The lots under GSMS, Inc.’s voluntary recall has been primarily sold to McKesson. McKesson are instructed to immediately stop distribution, quarantine all remaining products in their control, and return the recalled product to GSMS, inc. They are also instructed to provide their customers, i.e., pharmacies and consumers, a copy of GSMS, Inc.’s recall notification, recall response form, and letter to consumers, patients, and caregivers.
Consumers with questions regarding this recall can contact GSMS, Inc, by:
Phone: (800) 284-8633, ext. 116 (include days between 7:30 AM to 4:00 PM, Pacific)
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Golden State Medical Supply, Inc. Product Labeling and Carton Images: