Multi event Drug Recall Enforcement Report Class II voluntary initiated by PFIZER INC, originally initiated on 08-04-2025 for the product Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-6637-24. Case NDC: 00409-6637-14. The product was recalled due to lack of assurance of sterility.. 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-0591-2025 | 08-04-2025 | 08-27-2025 | Class II | 15,750 vials | Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-6637-24. Case NDC: 00409-6637-14. | Lack of Assurance of Sterility. | Ongoing |
| D-0590-2025 | 08-04-2025 | 08-27-2025 | Class II | 49,620 vials | Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045, USA. NDC 0409-4933-05. Case: NDC 0409-4933-10. | Lack of Assurance of Sterility. | Ongoing |
Recalled Products
