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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1471-2022 |
| Event ID | 90720 |
| Brand | TIMOLOL MALEATE |
| Generic Name | TIMOLOL |
| Manufacturer | TIMOLOL |
| Original Package? | 1 |
| Active Substance | TIMOLOL |
| Drug Route | OPHTHALMIC |
| Distribution | Distributed Nationwide in the USA |
| Quantity | 5,226 Cartons (60 vials/carton) |
| Recall Reason | Identification of an unknown impurity at the 12-month stability point. Further investigation has identified the impurity as Timolol Phenol S-Oxide. |
| Drug Classification | Class III |
| Drug Code Info | 20220907 |
| Product NDC | 17478-189 |
| Recall Initiation Date | 20220808 |
| Report Date | 20220907 |
| Classification Date | 20220829 |
| Address | 5605 Centerpoint Ct Ste B Gurnee, IL 60031-5278 United States |
| Recalling Firm | Akorn, Inc |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 817W3C6175 |
| Drug Application Number | ANDA212291 |
| 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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