Why it was recalled
Lack of Assurance of Sterility: Tamper Evidence Seal is missing on secondary container.
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).
Lot numbers, UPCs & expiration codes
Lot #s: a) GS049666, GS049807, Exp: 03/31/2024; b) GS049667, GS051447, Exp: 09/30/2024.
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0867-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 25, 2023
- FDA report date
- Jun 14, 2023
- Quantity
- 1,920 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Golden State Medical Supply Inc.
Original FDA data
Every field from FDA enforcement report D-0867-2023, exactly as published.
Show all FDA fields
- City
- Camarillo
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 92402
- Address
- 5187 Camino Ruiz
- Code information
- Lot #s: a) GS049666, GS049807, Exp: 03/31/2024; b) GS049667, GS051447, Exp: 09/30/2024.
- Postal code
- 93012-8601
- Report date
- Jun 14, 2023
- Product type
- Drugs
- Recall number
- D-0867-2023
- Classification
- Class II
- Recalling firm
- Golden State Medical Supply Inc.
- Product quantity
- 1,920 bottles
- Termination date
- Aug 8, 2025
- Reason for recall
- Lack of Assurance of Sterility: Tamper Evidence Seal is missing on secondary container.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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).
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- May 25, 2023
- Initial firm notification
- Letter
- Center classification date
- Jun 6, 2023