D-0577-2018 Class III Terminated
FDA drug recall D-0577-2018 was initiated by Akorn, Inc. on Feb 21, 2018 and is designated Class III. Reason for recall: Failed Stability Specification: OOS low viscosity results discovered during retain testing. The recall status is terminated (terminated Aug 31, 2020). Affected quantity: 31,812 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 14, 2018
- Initiation Date
- Feb 21, 2018
- Termination Date
- Aug 31, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 31,812 bottles
Product Description
Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-215-05
Reason for Recall
Failed Stability Specification: OOS low viscosity results discovered during retain testing.
Distribution Pattern
Nationwide in the USA
Code Information
Lot: 011037A
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0577-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026