D-0324-2015 Class I Terminated
FDA drug recall D-0324-2015 was initiated by Hospira Inc. on Sep 11, 2014 and is designated Class I. Reason for recall: Presence of Particulate Matter: A particulate, confirmed as human hair, was found sealed between the tube and film at the round seal of the unused administrative port of the container. The recall status is terminated (terminated Jan 4, 2016). Affected quantity: 63,378 flexible container units.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 31, 2014
- Initiation Date
- Sep 11, 2014
- Termination Date
- Jan 4, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 63,378 flexible container units
Product Description
HEPARIN SODIUM, 1000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), in 0.9% Sodium Chloride Injection, 500 mL flexible container unit, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-7620-03
Reason for Recall
Presence of Particulate Matter: A particulate, confirmed as human hair, was found sealed between the tube and film at the round seal of the unused administrative port of the container.
Distribution Pattern
Nationwide
Code Information
Lot #: 41-046-JT, Exp 11/01/2015
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0324-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026