Akorn, Inc.: Drug Recall
Recall #D-0265-2023 · 01/30/2023
Class III: Low Risk
Recall Details
- Recall Number
- D-0265-2023
- Classification
- Class III
- Product Type
- Drug
- Recalling Firm
- Akorn, Inc.
- Status
- Ongoing
- Date Initiated
- 01/30/2023
- Location
- Gurnee, IL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 45,117 Bottles
Reason for Recall
Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
Product Description
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
Distribution Pattern
Nationwide in the USA and Puerto Rico
Other Recalls by Akorn, Inc.
- Class II: Risk 04/26/2023
- Class II: Risk 04/26/2023
- Class II: Risk 04/26/2023
- Class II: Risk 04/26/2023
- Class II: Risk 04/26/2023
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.