FDAFDA · Food and drugs·Recall number D-1314-2022
Systane, Lubricant Eye Drops, Polyethylene Glycol 400 0.4% Lubricant, Propylene Glycol 0.3% Lubricant, Original, Long Lasting Dry Eye Relief, Sterile, a) 15 mL (0.5 FL OZ) NDC 0065-0429-15, b) 30 mL (1 FL OZ) NDC 0065-0429-30, bottle per box, Alcon Surgical Inc.
Published August 17, 2022 · Recall initiated: June 29, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: products were stored outside the drug label specifications.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- SYSTANE LUBRICANT
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Distributor
- Nationwide in the USA.
- Lot
- Part# a) 0065042915, b) 0065042930
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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