FDA Recalls Pataday Eye Allergy Drops Due to Storage Deviations
Mckesson Medical-Surgical is recalling Pataday Once Daily Relief eye drops nationwide because the products were stored outside label specifications. No illnesses have been reported.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall for CGMP storage deviations. No illnesses or injuries have been reported, and the hazard is theoretical rather than acute. This is a precautionary recall for a storage compliance violation.
Plain-English summary
Mckesson Medical-Surgical Inc. is recalling Pataday Once Daily Relief (olopatadine hydrochloride 0.2% ophthalmic solution) because the products were stored outside the conditions specified on the drug label. This storage deviation represents a Current Good Manufacturing Practice (CGMP) violation that could potentially affect the stability and efficacy of the medication.
The recalled product is a 2.5 mL sterile eye drop solution intended for once-daily relief of eye allergy itching. It was distributed nationwide in the United States. The affected product code is Part# 00065815001.
No illnesses or injuries have been reported in connection with this recall. Consumers who have purchased this product should stop using it and consult their pharmacist or healthcare provider for guidance.
The recalled product
- Product
- PATADAY ONCE DAILY RELIEF (OLOPATADINE HYDROCHLORIDE)
- Brand
- PATADAY ONCE DAILY RELIEF
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Ophthalmic / Eye Allergy
- Hazard
- improper-storage
- stability-concern
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 (1)
- Part# 00065815001
Distribution
Distributed nationwide across the United States.
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