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
Reported: September 7, 2022 Initiated: August 8, 2022 #D-1471-2022
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
Identification of an unknown impurity at the 12-month stability point. Further investigation has identified the impurity as Timolol Phenol S-Oxide.
Details
- Recalling Firm
- Akorn, Inc
- Units Affected
- 5,226 Cartons (60 vials/carton)
- Distribution
- Distributed Nationwide in the USA
- Location
- Gurnee, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Akorn, Inc. Units affected: 5,226 Cartons (60 vials/carton).
Why was this product recalled? ▼
Identification of an unknown impurity at the 12-month stability point. Further investigation has identified the impurity as Timolol Phenol S-Oxide.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 7, 2022. Severity: Low. Recall number: D-1471-2022.
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