RecallRadar

FDA Drug recall D-0382-2015

1% LIDOCAINE HCl Injection, USP, Preservative-Free, 10 mg/mL, 30 mL Single-dose vials, packaged in 25-count cartons, Rx only, Hospira, Inc.…

On 2015-02-11 the FDA classified a Class I recall of 1% LIDOCAINE HCl Injection, USP, Preservative-Free, 10 mg/mL, 30 mL Single-dose vials, packaged in 25-count cartons, Rx only, Hospira, Inc.… by Hospira, citing presence of Particulate Matter: Confirmed customer complaint that orange and black particulates, identified as iron oxide, were found embedded within the glass vial and floating i….

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0382-2015
ClassificationClass I
Statusterminated
Initiated2014-04-18
Published2015-02-11
Last updated2026-09-13 11:51 UTC
CompanyHospira
DistributionUS

Product

1% LIDOCAINE HCl Injection, USP, Preservative-Free, 10 mg/mL, 30 mL Single-dose vials, packaged in 25-count cartons, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4279-02.

Reason

Presence of Particulate Matter: Confirmed customer complaint that orange and black particulates, identified as iron oxide, were found embedded within the glass vial and floating in solution.

Identifiers

ndc0409-4713-12
ndc0409-4713-26
ndc0409-4713-02
ndc0409-4713-72
ndc0409-4713-62
ndc0409-4713-75
ndc0409-4713-65
ndc0409-4713-42
ndc0409-4713-25
ndc0409-4713-32
ndc0409-4278-16
ndc0409-4278-01
ndc0409-4279-16
ndc0409-4279-02
ndc0409-4776-10
ndc0409-4776-01
ndc0409-4282-11
ndc0409-4282-25
ndc0409-4282-01
ndc0409-4282-12
ndc0409-4282-02
ndc0409-4277-16
ndc0409-4277-01
ndc0409-4277-17
ndc0409-4277-02
ndc0409-4276-16
ndc0409-4276-01
ndc0409-4276-17
ndc0409-4276-02
ndc0409-4275-16
ndc0409-4275-01
code_infoLot number: 31-427-DK, Exp 01JUL2015.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0382-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.