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Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex Inc., Tor...

FDA Recall #D-0495-2025 — Class II — May 28, 2025

Recall #D-0495-2025 Date: May 28, 2025 Classification: Class II Status: Ongoing

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

Reason for Recall

Lack of Assurance of Sterility

Recalling Firm

Apotex Corp. — Weston, FL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

105,456 Bottles

Distribution

US Nationwide.

Code Information

Batch VD1654, Exp Date: 06/30/2027

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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