D-0867-2023 Class II Terminated
FDA drug recall D-0867-2023 was initiated by Golden State Medical Supply Inc. on May 25, 2023 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Tamper Evidence Seal is missing on secondary container. The recall status is terminated (terminated Aug 8, 2025). Affected quantity: 1,920 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Jun 14, 2023
- Initiation Date
- May 25, 2023
- Termination Date
- Aug 8, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,920 bottles
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.
Distribution pattern
Nationwide in the USA
Code information
Lot #s: a) GS049666, GS049807, Exp: 03/31/2024; b) GS049667, GS051447, Exp: 09/30/2024.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0867-2023
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026