Home / Recalls / Hospira Inc. / D-1147-2014

D-1147-2014 Class II Terminated

Recalled by Hospira Inc. — Lake Forest, IL

FDA drug recall D-1147-2014 was initiated by Hospira Inc. on Feb 10, 2014 and is designated Class II. Reason for recall: Presence of Particulate Matter: Confirmed customer report of visible particulate embedded in the glass vial. The recall status is terminated (terminated Feb 1, 2017). Affected quantity: 115,500 Vials.

Recall Details

Product Type: Drugs
Report Date: Mar 12, 2014
Initiation Date: Feb 10, 2014
Termination Date: Feb 1, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 115,500 Vials

Product Description

Bupivacaine HCl Inj. USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative Free Vial, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1162-02

Reason for Recall

Presence of Particulate Matter: Confirmed customer report of visible particulate embedded in the glass vial.

Distribution Pattern

Nationwide

Code Information

Lot 25-097-DK; Exp 01/01/2015

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1147-2014
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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