CLASS II Drug recall · Reported 20 Feb 2013 · FDA Enforcement Report

Propofol Injectable Emulsion recalled by Hospira

Hospira is recalling Propofol Injectable Emulsion, 1%, distributed nationwide in the US. The recall was initiated on 15 Nov 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: a) 95-070-DJ, Exp 11/01/12; 04-584-DJ, 04-652-DJ, Exp 04/01/13; 05-718-DJ, Exp 05/01/13; 06-815-DJ, Exp 06/01/13; b) 04-525-DJ, 04-530-DJ, 04-641-DJ-04-646-DJ, Exp 04/01/13; c) 02-291-DJ, Exp 02/01/13; 05-725-DJ, 05-732-DJ, Exp 05/01/13; 07-925-DJ, Exp 07/01/13; 09-065-DJ, Exp 09/01/13; 10-129-DJ, 10-133-DJ, 10-148-DJ, Exp 10/01/13, Note lot number may be followed by 01.

NDC0409-0010, 0409-4699, 0409-6010, 0409-1511, 0409-0501

Quantity recalled273,925 vials

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-159-2013
FDA event ID: 64062
Recalling firm: Hospira, Lake Forest, IL
Brand: Propofol
Manufacturer: Hospira, Inc.
Classification: Class II
Status: Terminated
Recall initiated: 15 Nov 2012
FDA classified: 8 Feb 2013
Reported: 20 Feb 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Particulate Matter
Drug class: Injectable & IV Drugs

Timeline

15 Nov 2012	Recall initiated by company
8 Feb 2013	Classified by FDA	+85 days
20 Feb 2013	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Presence of Particulate Matter: Visible particulate and particulate embedded in vials were observed during retain inspection.

Product as listed by the FDA

Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusion vial, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 50 mL Single patient infusion vial, 500 mg/50 mL (10 mg/mL), NDC 0409-4699-33; c) 100 mL Single patient infusion vial, 1 g/100 mL (10 mg/mL), NDC 0409-4699-24; Rx only, Hospira, Inc., Lake Forest, IL 60045 USA

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Presence of Particulate Matter: Visible particulate and particulate embedded in vials were observed during retain inspection.

Which lots are affected?

Lot #: a) 95-070-DJ, Exp 11/01/12; 04-584-DJ, 04-652-DJ, Exp 04/01/13; 05-718-DJ, Exp 05/01/13; 06-815-DJ, Exp 06/01/13; b) 04-525-DJ, 04-530-DJ, 04-641-DJ-04-646-DJ, Exp 04/01/13; c) 02-291-DJ, Exp 02/01/13; 05-725-DJ, 05-732-DJ, Exp 05/01/13; 07-925-DJ, Exp 07/01/13; 09-065-DJ, Exp 09/01/13; 10-129-DJ, 10-133-DJ, 10-148-DJ, Exp 10/01/13, Note lot number may be followed by 01.

Where was it sold?

Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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Other Propofol recalls

All 19

Reported	Class	Recall	Company	Reason	Where
21 Sep 2022Drug	CLASS I	Propofol Injectable Emulsion (10 mg/mL) recalled by PfizerPropofol	Pfizer	Particulate Matter	Nationwide
3 Aug 2022Drug	CLASS I	Propofol Injectable Emulsion (10 mg/mL) recalled by PfizerPropofol	Pfizer	Particulate Matter	Nationwide
15 Jun 2022Drug	CLASS II	Propofol Injectable Emulsion, USP 200 mg per (10 mg per mL) recalled	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide
15 Jun 2022Drug	CLASS II	Propofol Injectable Emulsion, USP, 200 mg/ (10 mg/mL) recalled	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide
15 Jun 2022Drug	CLASS II	Diprivan (Propofol) Emulsion, 100 mg/mL vial recalledDiprivan	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide