Drug product
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
D-1049-2017
Product summary
- Event
- Event 77533
- Status
- Terminated
- Classification
- Class II
- Quantity
- 21,436,700 5mL single dose vials
- Official record key
drug-enforcement:D-1049-2017
Official wording
Reason: Lack of Sterility Assurance
Code information: a.) one vial: Lot: 72226EV Exp. 12/01/2018 Lot: 72236EV Exp. 12/01/2018 Lot: 75382EV Exp. 03/01/2019 Lot: 75383EV Exp. 03/01/2019 b.) 25 vial carton: Lot: 7538EV; Exp 03/01/2019
Distribution pattern: U.S. (including Puerto Rico), Dutch Antilles, Barbados, Canada, Philippines, Kuwait, and Singapore
Derived failure modes
-
Sterility assurance
Lack of Sterility