Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex Inc., Toronto, Ontario, Canada,
Summary
The FDA issued a Class II for Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: by Apotex Corp.. Reason: Lack of Assurance of Sterility.
Details
Source
Drug Recall
External ID
D-0495-2025
Action Date
2025-07-02
Status
Ongoing
Category
drug
Product Description
Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0578-4
Lot/Code Info: Batch VD1654, Exp Date: 06/30/2027
Quantity Affected: 105,456 Bottles
Reason for Recall
Lack of Assurance of Sterility
Distribution
US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-28
Company
Weston, FL
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 57 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Apotex Corp. has 19 FDA actions in our database, including 18 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 (Apotex Corp.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Apotex Corp. have FDA actions?
Apotex Corp. has 19 FDA actions in our database, including 18 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0495-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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