D-0020-2015 Class I Terminated

Recalled by Hospira Inc. — Lake Forest, IL

FDA drug recall D-0020-2015 was initiated by Hospira Inc. on Jul 29, 2014 and is designated Class I. Reason for recall: Presence of Particulate Matter: The product was discolored and contained visible particulates (iron oxide) in the solution and embedded in the glass vial. The recall status is terminated (terminated Mar 17, 2017). Affected quantity: 109,110 Vials.

Recall Details

Product Type
Drugs
Report Date
Oct 22, 2014
Initiation Date
Jul 29, 2014
Termination Date
Mar 17, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
109,110 Vials

Product Description

Lidocaine HCl Injection, USP, 2%, 20 mg per mL, Preservative-Free, 5 mL Single-Dose Vial, Rx only, For Infiltration and Nerve Block including Epidural and Caudal, Manufactured by: Hospira, Inc., Lake Forest, IL, 60045, NDC 0409-2066-05

Reason for Recall

Presence of Particulate Matter: The product was discolored and contained visible particulates (iron oxide) in the solution and embedded in the glass vial.

Distribution Pattern

Nationwide

Code Information

Lot Number: 25-550-DD, Exp: 1JAN2015

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-0020-2015
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.