Reported Sep 7, 2022 · Ongoing
Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only, Sterile, Manufactured for:…
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 B · Gurnee, IL · 60031-5278
Is this the product you have?
- Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only, Sterile
- Manufactured forAkorn, Inc., Lake Forest, IL 60045. NDC 17478-189-24
- Lot codes and dates
Lot #: 9N72EXP 09/30/2022
- Amount recalled
- 5,226 Cartons (60 vials/carton)
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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