Multi event Drug Recall Enforcement Report Class I voluntary initiated by Pfizer Inc., originally initiated on 10-02-2023 for the product 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 The product was recalled due to presence of particulate matter: identified as glass.. The product was distributed nationwide and the recall is currently ongoing.
Recall Enforcement Reports
Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
D-0102-2024 | 10-02-2023 | 11-15-2023 | Class I | 3,200 vials | 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 | Presence of Particulate Matter: identified as glass. | Ongoing |
D-0100-2024 | 10-02-2023 | 11-15-2023 | Class I | 24,900 vials | 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-5534-24 | Presence of Particulate Matter: identified as glass. | Ongoing |
D-0101-2024 | 10-02-2023 | 11-15-2023 | Class I | 21,390 vials | 1% Lidocaine HCl Injection, USP, 50mg/5mL(10mg/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 0409-4904-11 | Presence of Particulate Matter: identified as glass. | Ongoing |
Recalled Products
NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
0409-1323 | Lidocaine Hydrochloride | Lidocaine Hydrochloride | Injection, Solution | Intravenous | Hospira, Inc. | Human Prescription Drug |
0409-4903 | Lidocaine Hydrochloride | Lidocaine Hydrochloride | Injection, Solution | Intravenous | Hospira, Inc. | Human Prescription Drug |
0409-4904 | Lidocaine Hydrochloride | Lidocaine Hydrochloride | Injection, Solution | Intravenous | Hospira, Inc. | Human Prescription Drug |
0409-5534 | Sodium Bicarbonate | Sodium Bicarbonate | Injection, Solution | Intravenous | Hospira, Inc. | Human Prescription Drug |
0409-9137 | Lidocaine Hydrochloride | Lidocaine Hydrochloride | Injection, Solution | Intravenous | Hospira, Inc. | Human Prescription Drug |