Class III
Ongoing
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
- Company
- Akorn, Inc
- Recall Initiated
- August 8, 2022
- Posted
- September 7, 2022
- Recall Number
- D-1471-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 5,226 Cartons (60 vials/carton)
- Firm Location
- Gurnee, IL, United States
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.
Distribution
Distributed Nationwide in the USA
Lot / Code Info
Lot #: 9N72, EXP 09/30/2022
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