Reported Feb 15, 2023 · Ongoing
Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL bottle, Sterile, Rx only,…
Akorn, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Akorn, Inc. · 5605 Centerpoint Ct Ste A · Gurnee, IL · 60031-5278
Is this the product you have?
- Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL bottle, Sterile, Rx only
- Distributed byAkorn Operating Company LLC, Gurnee, IL 60031
- NDC17478-215-02
- Lot codes and dates
- Lot
081031AExp 2/28/2023
- Lot
- Amount recalled
- 45,117 Bottles
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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