Akorn, Inc: Drug Recall
Recall #D-1471-2022 · 08/08/2022
Class III: Low Risk
Recall Details
- Recall Number
- D-1471-2022
- Classification
- Class III
- Product Type
- Drug
- Recalling Firm
- Akorn, Inc
- Status
- Ongoing
- Date Initiated
- 08/08/2022
- Location
- Gurnee, IL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,226 Cartons (60 vials/carton)
Reason for Recall
Identification of an unknown impurity at the 12-month stability point. Further investigation has identified the impurity as Timolol Phenol S-Oxide.
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
Distribution Pattern
Distributed Nationwide in the USA
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.