Reported Mar 14, 2018 · Terminated
Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake…
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. · 1925 W Field Ct Ste 300 · Lake Forest, IL · 60045-4862
Is this the product you have?
- Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Only
- Manufactured byAkorn, Inc., Lake Forest, IL 60045
- NDC17478-215-05
- Lot codes and dates
- Lot011037A
- Amount recalled
- 31,812 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Stability Specification: OOS low viscosity results discovered during retain testing.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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