Azelastine HCl Ophthalmic Solution recall: Sterility Concern
Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Mfg. for: Apotex…
Why was Azelastine HCl Ophthalmic Solution recalled?
Lack of Assurance of Sterility
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Batch VD1654, Exp Date: 06/30/2027
- Product
- Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Mfg. for: Apotex…
- Recalling firm
- Apotex Corp.
- Quantity
- 105,456 Bottles
- Distribution
- US Nationwide.
- Recall date
- July 2, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)