The Recall Desk
HighFDA (Drugs)·D-0867-2023·Announced 2023-06-14

Eye Drops Recalled: Travoprost Missing Tamper Evidence Seal

Golden State Medical Supply is recalling Travoprost eye drops due to missing tamper evidence seals on some bottles. The missing seal prevents sterility assurance on 1,920 units distributed nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall for missing tamper evidence seal on an ophthalmic solution creates risk of sterility compromise. No illnesses or injuries have been reported, making this a risk-of-harm situation without confirmed adverse events.

Plain-English summary

Travoprost Ophthalmic Solution, USP 0.004% is a prescription eye medication manufactured by Golden State Medical Supply Inc. and Apotex Inc. The company is recalling specific lots due to a manufacturing defect.

The recalled products have missing tamper evidence seals on the secondary container. This defect prevents assurance that the medication meets required sterility standards, which is critical for products applied directly to the eye.

The recall affects 1,920 bottles distributed nationwide with the following affected lot numbers: GS049666 and GS049807 (expiring March 31, 2024) and GS049667 and GS051447 (expiring September 30, 2024). The affected products are available in 2.5 mL bottles (NDC 51407-731-25) and 5 mL bottles (NDC 51407-731-05).

Patients currently using medication from the affected lots should contact their pharmacist or healthcare provider immediately. Do not continue use of any bottles with missing or damaged tamper evidence seals.

The recalled product

Product
TRAVOPROST (TRAVOPROST)
Brand
TRAVOPROST
Manufacturer
Golden State Medical Supply Inc.
Hazard
  • missing-tamper-seal
  • sterility-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • Lot #s: a) GS049666
  • GS049807
  • Exp: 03/31/2024
  • b) GS049667
  • GS051447
  • Exp: 09/30/2024.

Distribution

Distributed nationwide across the United States.