FDAFDA · Food and drugs·Recall number D-0265-2023
Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL bottle, Sterile, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. NDC: 17478-215-02
Published February 15, 2023 · Recall initiated: January 30, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Akorn, Inc.
- Distributor
- Nationwide in the USA and Puerto Rico
- Lot
- Lot: 081031A, Exp 2/28/2023
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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