FDA Recalls SYSTANE Lubricant Eye Drops Due to Improper Storage
McKesson Medical-Surgical Inc. is recalling 47 bottles of SYSTANE Lubricant Eye Drops nationwide. The products were stored outside label specifications, violating manufacturing practices.
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 with no reported illnesses or injuries. The hazard—improper storage—is theoretical, with no evidence of actual harm reported in the source, making this a precautionary quality-based recall.
Plain-English summary
SYSTANE Lubricant Eye Drops (Polyethylene Glycol 400 0.4% and Propylene Glycol 0.3%) in 15 mL and 30 mL bottles are being recalled by McKesson Medical-Surgical Inc. The affected NDC codes are 0065-0429-15 and 0065-0429-30.
The FDA issued this recall because the products were stored outside the manufacturer's labeled storage specifications, which constitutes a Current Good Manufacturing Practices (CGMP) deviation. Products not stored according to label requirements may not maintain their intended quality, efficacy, or safety.
The affected 47 bottles were distributed nationwide in the United States. If you have purchased these eye drops, discontinue use and contact your pharmacy or McKesson Medical-Surgical Inc. for a replacement or refund.
The recalled product
- Product
- SYSTANE LUBRICANT (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL)
- Brand
- SYSTANE LUBRICANT
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Ophthalmic / Eye Care
- 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 (2)
- Part# a) 0065042915
- b) 0065042930
Distribution
Distributed nationwide across the United States.
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