D-1815-2015 Class II Ongoing

Recalled by Hospira, Inc. — Lake Forest, IL

FDA drug recall D-1815-2015 was initiated by Hospira, Inc. on Aug 25, 2015 and is designated Class II. Reason for recall: Presence of Particulate Matter: particulate matter identified as iron oxide, was found embedded in the neck of glass vials. The recall status is ongoing. Affected quantity: 100,200 Vials.

Recall Details

Product Type
Drugs
Report Date
Sep 30, 2015
Initiation Date
Aug 25, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
100,200 Vials

Product Description

1% Lidocaine HCl Injection, USP, 10 mg/mL, 30 mL Vial, Single-dose Preservative Free, Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-4279-02

Reason for Recall

Presence of Particulate Matter: particulate matter identified as iron oxide, was found embedded in the neck of glass vials.

Distribution Pattern

Nationwide

Code Information

Lot #: 44-359-DK, Exp 08/01/2016

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-1815-2015
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.