D-0265-2023 Class III Ongoing
FDA drug recall D-0265-2023 was initiated by Akorn, Inc. on January 30, 2023 and is designated Class III. Reason for recall: Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint. The recall status is ongoing. Affected quantity: 45,117 Bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- February 15, 2023
- Initiation Date
- January 30, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 45,117 Bottles
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
Reason for Recall
Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
Distribution Pattern
Nationwide in the USA and Puerto Rico
Code Information
Lot: 081031A, Exp 2/28/2023