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

FDA recall notice · announced September 7, 2022 · Akorn

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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

Reason for recall

Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point.

Notes

Distribution: Distributed Nationwide in the USA
Lot/code information: Lot #: 9N72, EXP 09/30/2022
Quantity: 5,226 Cartons (60 vials/carton)
Status: Ongoing
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.