CLASS II Drug recall · Reported 14 Jun 2023 · FDA Enforcement Report
Travoprost Ophthalmic Solution recalled by Golden State Medical Supply
Golden State Medical Supply is recalling Travoprost Ophthalmic Solution, USP (Ionic Buffered Solution), 0.004%, distributed nationwide in the US. The recall was initiated on 25 May 2023 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0867-2023
- FDA event ID
- 92402
- Recalling firm
- Golden State Medical Supply, Camarillo, CA
- Brand
- Travoprost
- Manufacturer
- Golden State Medical Supply, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 May 2023
- FDA classified
- 6 Jun 2023
- Reported
- 14 Jun 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Eye Drops
Timeline
| 25 May 2023 | Recall initiated by company | |
| 6 Jun 2023 | Classified by FDA | +12 days |
| 14 Jun 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: Tamper Evidence Seal is missing on secondary container.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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).
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: Tamper Evidence Seal is missing on secondary container.
Which lots are affected?
Lot #s: a) GS049666, GS049807, Exp: 03/31/2024; b) GS049667, GS051447, Exp: 09/30/2024.
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Golden State Medical Supply
All 55| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Prasugrel HCI, Tablets, USP, 10mg recalledPrasugrel | Golden State Medical Supply | Potency & Assay | Nationwide |
| Drug | CLASS II | Carbamazepine Tablets, USP, 200mg recalled | Golden State Medical Supply | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Gsms Incorporated, Niacin Extended-release Tablets, USP, 1,000 MG recalledNiacin | Golden State Medical Supply | Potency & Assay | CA |
| Drug | CLASS III | Primidone Tablets, USP, 250 mg recalled by Golden State Medical SupplyPrimidone | Golden State Medical Supply | Other | Nationwide |
| Drug | CLASS III | Primidone Tablets, USP, 50 mg recalled by Golden State Medical SupplyPrimidone | Golden State Medical Supply | Other | Nationwide |
Other Travoprost recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Travoprost Ophthalmic Solution recalled by Mylan PharmaceuticalsTravoprost Ophthalmic Solution, 0.004% | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Travoprost Ophthalmic Solution recalled by Cardinal Health | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Travoprost Ophthalmic Solution USP, 0.004%, a) and b) recalled | Par Pharmaceutical | Sterility | Nationwide |