RecallRadar

FDA Drug recall D-0389-2015

Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vials, packaged in 5 Units per carton, Rx only, Ho…

On 2015-02-25 the FDA classified a Class I recall of Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vials, packaged in 5 Units per carton, Rx only, Ho… by Hospira, citing temperature Abuse: Products experienced uncontrolled temperature excursions during transit.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0389-2015
ClassificationClass I
Statusterminated
Initiated2014-10-06
Published2015-02-25
Last updated2026-09-13 11:51 UTC
CompanyHospira
DistributionUS

Product

Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vials, packaged in 5 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.

Reason

Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.

Identifiers

ndc0409-4699-50
ndc0409-4699-30
ndc0409-4699-53
ndc0409-4699-33
ndc0409-4699-54
ndc0409-4699-24
ndc0409-6010-02
ndc0409-6010-25
ndc0409-1511-97
ndc0409-1511-98
ndc0409-0501-97
ndc0409-0501-98
ndc0409-0010-97
ndc0409-0010-98
code_infoOne shipment of Lot #: 33-750-DJ; Exp 1SEP2015 to The Harvard Drug Group, Livonia, MI

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-0389-2015%22

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