Drug product
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
D-1046-2017
Product summary
- Event
- Event 77533
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20,337,650 15 mL single dose vials
- Official record key
drug-enforcement:D-1046-2017
Official wording
Reason: Lack of Sterility Assurance
Code information: Lot: 74119EV Exp. 02/01/2019 Lot: 74120EV Exp. 02/01/2019 Lot: 74121EV Exp. 02/01/2019 Lot: 74307EV Exp. 02/01/2019 Lot: 75326EV Exp. 03/01/2019 Lot: 75327EV Exp. 03/01/2019 Lot: 75215EV 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