LIDOCAINE HYDROCHLORIDE Recall D-1495-2022
Description: Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-711-31
LIDOCAINE HYDROCHLORIDE Recall D-1495-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1495-2022 |
| Event ID | 90813 |
| Brand | LIDOCAINE |
| Generic Name | LIDOCAINE HYDROCHLORIDE |
| Manufacturer | LIDOCAINE HYDROCHLORIDE |
| Original Package? | 1 |
| Active Substance | LIDOCAINE HYDROCHLORIDE |
| Drug Route | TOPICAL |
| Distribution | USA nationwide |
| Quantity | 82,689 tubes |
| Recall Reason | cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause. |
| Drug Classification | Class II |
| Drug Code Info | 20220914 |
| Product NDC | 17478-711 |
| Drug UPC | 0317478711100 |
| Recall Initiation Date | 20220831 |
| Report Date | 20220914 |
| Classification Date | 20220906 |
| Address | 5605 Centerpoint Ct Ste A Gurnee, IL 60031-5278 United States |
| Recalling Firm | Akorn, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | V13007Z41A |
| Drug Application Number | ANDA040433 |
| Structured Product Labeling (SPL ID) | cabfb396-7b14-40b5-a647-634e907e2d3c |
| Structured Product Labeling (SPL Set ID) | 317a8784-5fdd-429f-9b74-14d89f372a32 |
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