LIDOCAINE HYDROCHLORIDE ANHYDROUS Recall D-0846-2022
Description: Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100 mL per bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701, NDC 50383-775-04
LIDOCAINE HYDROCHLORIDE ANHYDROUS Recall D-0846-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0846-2022 |
| Event ID | 89993 |
| Brand | LIDOCAINE HYDROCHLORIDE |
| Generic Name | LIDOCAINE HYDROCHLORIDE |
| Manufacturer | LIDOCAINE HYDROCHLORIDE |
| Original Package? | 1 |
| Active Substance | LIDOCAINE HYDROCHLORIDE ANHYDROUS |
| Drug Route | ORAL |
| Distribution | Nationwide USA and Puerto Rico |
| Quantity | 66,744 bottles |
| Recall Reason | Failed viscosity specification - product was below specificcation |
| Drug Classification | Class III |
| Drug Code Info | 20220511 |
| Product NDC | 50383-775 |
| Recall Initiation Date | 20220415 |
| Report Date | 20220511 |
| Classification Date | 20220505 |
| Address | 1925 W Field Ct Ste 300 Lake Forest, IL 60045-4862 United States |
| Recalling Firm | Akorn, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | EC2CNF7XFP |
| Drug Application Number | ANDA040014 |
| Structured Product Labeling (SPL ID) | c98571bd-002b-4745-b27e-3b11e6a3af47 |
| Structured Product Labeling (SPL Set ID) | ff6b27bc-2ed7-4292-b8c8-da910bf68167 |
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