FDA Recalls ZADITOR Eye Drops Due to Improper Storage Conditions
ZADITOR eye drops were stored outside FDA label specifications in a nationwide Class II recall affecting 9 boxes distributed by McKesson Medical-Surgical Inc.
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: This is a FDA Class II drug recall with no reported illnesses or injuries. The storage deviation represents a risk-of-harm situation, but without evidence of actual harm, it meets the High severity criterion per the rubric.
Plain-English summary
ZADITOR (ketotifen fumarate) ophthalmic solution 0.035% is an over-the-counter antihistamine eye drop product. The recalled product is Systane Zaditor in 5mL bottles (Part# 0065401105, NDC 0065-4011-05), manufactured by Alcon and distributed by McKesson Medical-Surgical Inc. Nine boxes of this product were distributed nationwide in the USA.
McKesson Medical-Surgical Inc. initiated the recall because the affected ZADITOR bottles were stored outside the storage conditions specified on the drug label. This storage deviation is a Current Good Manufacturing Practice (CGMP) violation that may affect product stability or efficacy. The FDA classified this recall as Class II.
Consumers who have purchased ZADITOR with the affected product code should contact McKesson Medical-Surgical Inc. or the FDA for guidance. The product can be identified by Part# 0065401105.
The recalled product
- Product
- ZADITOR (KETOTIFEN FUMARATE)
- Brand
- ZADITOR
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Ophthalmic
- Hazard
- improper-storage
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# 0065401105
UPCs (1)
- 0300654011057
Distribution
Distributed nationwide across the United States.
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