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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Affected units
- 1
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.
Part of a larger recall action
This product is one of 17 recalled by Mckesson Medical-Surgical Inc. Corporate Office under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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