Drug Enforcement D-0867-2023

Lack of Assurance of Sterility: Tamper Evidence Seal is missing on secondary container.

Status

Terminated

Classification

Class II

Report Date

June 14, 2023

Termination Date

August 8, 2025

Product Information

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).
Product quantity
1,920 bottles
Reason for recall
Lack of Assurance of Sterility: Tamper Evidence Seal is missing on secondary container.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Golden State Medical Supply Inc.
Address
5187 Camino Ruiz

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0867-2023
Event ID
92402
Recall initiation date
May 25, 2023
Center classification date
June 6, 2023
Code info
Lot #s: a) GS049666, GS049807, Exp: 03/31/2024; b) GS049667, GS051447, Exp: 09/30/2024.
More code info
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