Drug product
Potassium Chloride for Inj. Concentrate, USP, 40 mEq (2 mEq/mL), 20 mL Single-dose Fliptop Vial, For IV use, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA
D-1261-2014
Product summary
- Firm
- Hospira Inc.
- Event
- Event 67935
- Status
- Terminated
- Classification
- Class II
- Quantity
- 255,900 vials
- Official record key
drug-enforcement:D-1261-2014
Official wording
Reason: Presence of Particulate; red and black particulate within the solution and embedded within the plastic vial identified as iron oxide
Code information: Lot 22-127-DK
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate