Multi event Drug Recall Enforcement Report Class II voluntary initiated by Hospira a Pfizer Company, originally initiated on 06-15-2017 for the product 8.4% Sodium Bicarbonate Inj., USP 50 mL Single-dose, 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL), Rx Only, Mfd by Hospira, INC, Lake Forest, IL 60045 USA, NDC: 0409-6625-02 The product was recalled due to lack of sterility assurance. The product was distributed in U.s. (including Puerto Rico), Dutch Antilles, Barbados, Canada, Philippines, Kuwait, And Singapore and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-1047-2017 | 06-15-2017 | 08-09-2017 | Class II | 91,483,150 50 mL single dose vials | 8.4% Sodium Bicarbonate Inj., USP 50 mL Single-dose, 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL), Rx Only, Mfd by Hospira, INC, Lake Forest, IL 60045 USA, NDC: 0409-6625-02 | Lack of Sterility Assurance | Terminated |
| D-1049-2017 | 06-15-2017 | 08-09-2017 | Class II | 21,436,700 5mL single dose vials | Neut Sodium Bicarbonate 4% (2.4 mEq) Additive Solution 5 mL , a.) Single-dose vial (NDC 0409-6609-02), b.) 25 vial carton (NDC 0409-6609-25), Rx Only, Mfd by Hospira, INC, Lake Forest, IL 60045 USA | Lack of Sterility Assurance | Terminated |
| D-1046-2017 | 06-15-2017 | 08-09-2017 | Class II | 20,337,650 15 mL single dose vials | Potassium Phosphates Inj., USP, 45 mM (3 mM P/mL) Also contains: 66 mEq K+ (4.4 mEq/mL) 15 mL, Single-dose, Caution: Must Be Diluted, Rx Only, Mfd by Hospira, Inc. Lake Forest, IL 60045 USA, NDC: 0409-7295-01 | Lack of Sterility Assurance | Terminated |
| D-1048-2017 | 06-15-2017 | 08-09-2017 | Class II | 15,034,600 10 mL multiple dose use vials | Succinylcholine Chloride Injection, USP 200 mg (20 mg/mL) Quelicin Multiple-dose vial, 10 mL, For I.V. or I.M. use. a.) one vial (NDC: 0409-6629-02), b.) 25 vial carton (NDC: 0409-6629-25). | Lack of Sterility Assurance | Terminated |
Recalled Products
| NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
| 0409-6629 | Quelicin | | | | Hospira, Inc. | |
| 0409-6629 | Quelicin | Succinylcholine Chloride | Injection, Solution | Intramuscular; Intravenous | Hospira, Inc. | Human Prescription Drug |
| 0409-6970 | Quelicin | | | | Hospira, Inc. | |
| 0409-7295 | Potassium Phosphates | | | | Hospira, Inc. | |
| 0409-7295 | Potassium Phosphates | Potassium Phosphate, Monobasic And Potassium Phosphate, Dibasic | Injection, Solution, Concentrate | Intravenous | Hospira, Inc. | Human Prescription Drug |
