Home / Recalls / Hospira Inc. / D-380-2014

D-380-2014 Class I Terminated

Recalled by Hospira Inc. — Lake Forest, IL

FDA drug recall D-380-2014 was initiated by Hospira Inc. on Jul 12, 2013 and is designated Class I. Reason for recall: Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials. The recall status is terminated (terminated Feb 3, 2015). Affected quantity: 118,100 vials.

Recall Details

Product Type: Drugs
Report Date: Dec 25, 2013
Initiation Date: Jul 12, 2013
Termination Date: Feb 3, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 118,100 vials

Product Description

0.25% Bupivacaine HCl Injection, USP, 2.5 mg/mL, 30 mL, Single-dose, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1159-02

Reason for Recall

Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.

Distribution Pattern

Nationwide

Code Information

Lot # 18-136-DK; Exp. 6/14

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-380-2014
openFDA file date: Oct 27, 2026
Loaded by RegDataLab: Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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