Recalls / Class II
Class IID-1261-2014
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
- Affected lot / code info
- Lot 22-127-DK
Why it was recalled
Presence of Particulate; red and black particulate within the solution and embedded within the plastic vial identified as iron oxide
Recalling firm
- Firm
- Hospira Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, N/A, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 255,900 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-03-27
- FDA classified
- 2014-04-24
- Posted by FDA
- 2014-04-30
- Terminated
- 2015-06-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1261-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.