FDA Drug recall D-0381-2015

Propofol Injectable Emulsion, 1%, 200 mg/20 mL, (10mg/mL), 20 mL, Single patient infusion vial, Contains Benzyl Alcohol, For I.V. Administr…

• FDA Drug
• Class II
• terminated
• Published 2015-02-04

On 2015-02-04 the FDA classified a Class II recall of Propofol Injectable Emulsion, 1%, 200 mg/20 mL, (10mg/mL), 20 mL, Single patient infusion vial, Contains Benzyl Alcohol, For I.V. Administr… by Hospira, citing presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron.

Read the official FDA Drug notice

Product

Propofol Injectable Emulsion, 1%, 200 mg/20 mL, (10mg/mL), 20 mL, Single patient infusion vial, Contains Benzyl Alcohol, For I.V. Administration, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30

Reason

Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron.

Identifiers

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-0381-2015%22

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