D-1471-2022 Class III Ongoing
FDA drug recall D-1471-2022 was initiated by Akorn, Inc on Aug 8, 2022 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point. The recall status is ongoing. Affected quantity: 5,226 Cartons (60 vials/carton).
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 7, 2022
- Initiation Date
- Aug 8, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,226 Cartons (60 vials/carton)
Product Description
Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only, Sterile, Manufactured for: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-189-24
Reason for Recall
Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point.
Distribution Pattern
Distributed Nationwide in the USA
Code Information
Lot #: 9N72, EXP 09/30/2022
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1471-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026