LIDOCAINE HYDROCHLORIDE Recall D-0102-2024
Description: 2% Lidocaine HCl Injection, USP, 100mg/5mL(20mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Distributed by Hospira Inc., Lake Forest, IL 60045, NDC 0409-4903-11
LIDOCAINE HYDROCHLORIDE Recall D-0102-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0102-2024 |
| Event ID | 93124 |
| Brand | LIDOCAINE HYDROCHLORIDE |
| Generic Name | LIDOCAINE HYDROCHLORIDE |
| Manufacturer | LIDOCAINE HYDROCHLORIDE |
| Original Package? | 1 |
| Active Substance | LIDOCAINE HYDROCHLORIDE |
| Drug Route | INTRAVENOUS |
| Distribution | Nationwide in the US and Puerto Rico. The products were not distributed to government accounts or foreign consignees. |
| Quantity | 3,200 vials |
| Recall Reason | Presence of Particulate Matter: identified as glass. |
| Drug Classification | Class I |
| Drug Code Info | 20231115 |
| Product NDC | 0409-1323 0409-4903 0409-4904 |
| Recall Initiation Date | 20231002 |
| Report Date | 20231115 |
| Classification Date | 20231109 |
| Address | 235 East 42nd Street New York, NY 10017-5703 United States |
| Recalling Firm | Pfizer Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | V13007Z41A |
| Drug Application Number | ANDA040302 |
| Structured Product Labeling (SPL ID) | 3a6e4402-7b97-4d62-8239-16c2ff17009d |
| Structured Product Labeling (SPL Set ID) | ad1ef0a8-88db-4648-c098-d009eaeb4e5b |
| Similar To |