Product Safety Recalls

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TIMOLOL Recall D-1471-2022

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

TIMOLOL Recall D-1471-2022 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-1471-2022
Event ID90720
Generic NameTIMOLOL
Original Package?1
Active SubstanceTIMOLOL
DistributionDistributed Nationwide in the USA
Quantity5,226 Cartons (60 vials/carton)
Recall ReasonIdentification of an unknown impurity at the 12-month stability point. Further investigation has identified the impurity as Timolol Phenol S-Oxide.
Drug ClassificationClass III
Drug Code Info20220907
Product NDC17478-189
Recall Initiation Date20220808
Report Date20220907
Classification Date20220829
Address5605 Centerpoint Ct Ste B
Gurnee, IL 60031-5278
United States
Recalling FirmAkorn, Inc
Initial Notification Letter
Unique Ingredient Identifier817W3C6175
Drug Application NumberANDA212291
Structured Product Labeling (SPL ID)54f834c6-e4fc-477a-aeb8-426de2590232
Structured Product Labeling (SPL Set ID)b969bb47-6b4a-46ee-93cc-52faee4369c4
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