Recall Enforment Report D-0215-2019
Recall Details
Multi event Drug Recall Enforcement Report Class II voluntary initiated by ICU Medical Inc, originally initiated on 10-08-2018 for the product 5% Dextrose Injection, USP, Rx Only, a) 25 mL NDC 0409-7923-20; b) 250 mL NDC 0409-7922-02, Hospira, Inc. Lake Forest, IL 60045 The product was recalled due to lack of assurance of sterility; bags have the potential to leak. The product was distributed nationwide 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-0215-2019 | 10-08-2018 | 11-14-2018 | Class II | 372,912 bags | 5% Dextrose Injection, USP, Rx Only, a) 25 mL NDC 0409-7923-20; b) 250 mL NDC 0409-7922-02, Hospira, Inc. Lake Forest, IL 60045 | Lack of Assurance of Sterility; bags have the potential to leak | Terminated |
| D-0216-2019 | 10-08-2018 | 11-14-2018 | Class II | 2,580,448 bags | 0.9% Sodium Chloride Injection, USP Rx Only a) 250 mL NDC 0409-7983-02; b) 150 mL NDC 0409-7983-61; c) 50 mL NDC 0409-7984-36; d) 100 mL NDC 0409-7984-37, Hospira, Inc. Lake Forest, IL 60045 | Lack of Assurance of Sterility; bags have the potential to leak | Terminated |
