Drug recall D-0495-2025

Class II Ongoing reported Jul 2, 2025

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 Corp., Weston, FL 33326, NDC 60505-0578-4

Reason for recall

Lack of Assurance of Sterility

Lots and codes

Batch VD1654, Exp Date: 06/30/2027

Recall details

Recalling firm
Apotex Corp., Weston, FL
Quantity
105,456 Bottles
Distribution
US Nationwide.
Type
Voluntary: Firm initiated
Recall initiated
May 28, 2025

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