RecallRadar

FDA Drug recall D-0898-2017

Levophed norepinephrine bitartrate, injection, USP, 4 mg /4 mL (1 mg/mL),Rx only, Hospira, Inc

On 2017-06-21 the FDA classified a Class II recall of Levophed norepinephrine bitartrate, injection, USP, 4 mg /4 mL (1 mg/mL),Rx only, Hospira, Inc by Hospira A Pfizer, citing GMP Deviation; A foreign stopper was observed during packaging of a lot of product.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0898-2017
ClassificationClass II
Statusterminated
Initiated2017-05-18
Published2017-06-21
Last updated2026-09-13 11:51 UTC
CompanyHospira A Pfizer
DistributionUS

Product

Levophed norepinephrine bitartrate, injection, USP, 4 mg /4 mL (1 mg/mL),Rx only, Hospira, Inc. Lake Forest, IL --- NDC 0409-3375-04

Reason

GMP Deviation; A foreign stopper was observed during packaging of a lot of product.

Identifiers

ndc0409-3375-14
ndc0409-3375-04
ndc0409-1443-14
ndc0409-1443-04
code_info720503A, 720603A (Canada only)

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-0898-2017%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.