Azelastine Hydrochloride Ophthalmic Solution Recalled for Lack of Sterility Assurance
Apotex Corp. is recalling 105,456 bottles of Azelastine Hydrochloride Ophthalmic Solution distributed nationwide due to lack of assurance of sterility. Patients should stop using the product and contact their healthcare provider.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or confirmed contamination. The hazard is theoretical—lack of sterility assurance in a sterile pharmaceutical product—where injury has not yet been reported. This qualifies as a risk-of-harm product per the rubric.
Plain-English summary
Apotex Corp. is recalling batch VD1654 of Azelastine Hydrochloride Ophthalmic Solution USP 0.05%, 6 mL bottles (NDC 60505-0578-4) with an expiration date of June 30, 2027. The product is a prescription eye medication manufactured by Apotex Inc. in Toronto, Ontario, Canada.
The recall is due to lack of assurance of sterility.
Approximately 105,456 bottles were distributed nationwide in the United States.
Patients who received or are using the recalled product should stop using it immediately and contact their healthcare provider or pharmacist for guidance. The recalled batch can be identified by lot number VD1654 on the label.
The recalled product
- Product
- AZELASTINE HYDROCHLORIDE (AZELASTINE HYDROCHLORIDE)
- Brand
- AZELASTINE HYDROCHLORIDE
- Manufacturer
- Apotex Corp.
- Category
- Drug — Ophthalmic Solution
- Hazard
- sterility-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Batch VD1654
- Exp Date: 06/30/2027
Distribution
Distributed nationwide across the United States.
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