Drug product
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
D-1471-2022
Product summary
- Firm
- Akorn, Inc
- Event
- Event 90720
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 5,226 Cartons (60 vials/carton)
- Official record key
drug-enforcement:D-1471-2022
Official wording
Reason: Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point.
Code information: Lot #: 9N72, EXP 09/30/2022
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications