Travoprost Ophthalmic Solution, USP (Ionic Buffered Solution), 0.004%, Rx only, Manufactured by Apotex Inc., Manufactur
Summary
The FDA issued a Class II for Travoprost Ophthalmic Solution, USP (Ionic Buffered Solution), 0.004%, Rx only, by Golden State Medical Supply Inc.. Reason: Lack of Assurance of Sterility: Tamper Evidence Seal is missing on secondary container..
Details
Source
Drug Recall
External ID
D-0867-2023
Action Date
2023-06-14
Status
Terminated
Category
drug
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/Code Info: Lot #s: a) GS049666, GS049807, Exp: 03/31/2024; b) GS049667, GS051447, Exp: 09/30/2024.
Quantity Affected: 1,920 bottles
Reason for Recall
Lack of Assurance of Sterility: Tamper Evidence Seal is missing on secondary container.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-25
Company
Camarillo, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 122 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Golden State Medical Supply Inc. has 23 FDA actions in our database, including 23 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Golden State Medical Supply Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Golden State Medical Supply Inc. have FDA actions?
Golden State Medical Supply Inc. has 23 FDA actions in our database, including 23 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0867-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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