D-1261-2014 Class II Terminated
FDA drug recall D-1261-2014 was initiated by Hospira Inc. on Mar 27, 2014 and is designated Class II. Reason for recall: Presence of Particulate; red and black particulate within the solution and embedded within the plastic vial identified as iron oxide The recall status is terminated (terminated Jun 30, 2015). Affected quantity: 255,900 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Apr 30, 2014
- Initiation Date
- Mar 27, 2014
- Termination Date
- Jun 30, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 255,900 vials
Product Description
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
Reason for Recall
Presence of Particulate; red and black particulate within the solution and embedded within the plastic vial identified as iron oxide
Distribution Pattern
Nationwide
Code Information
Lot 22-127-DK
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1261-2014
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026