FDA Drug recall D-159-2013
Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusion vial, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30
- FDA Drug
- Class II
- terminated
- Published 2013-02-20
On 2013-02-20 the FDA classified a Class II recall of Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusion vial, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30 by Hospira, citing presence of Particulate Matter: Visible particulate and particulate embedded in vials were observed during retain inspection.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-159-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-11-15 |
| Published | 2013-02-20 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Hospira |
| Distribution | US |
Product
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
Reason
Presence of Particulate Matter: Visible particulate and particulate embedded in vials were observed during retain inspection.
Identifiers
| ndc | 0409-4699-50 |
|---|---|
| ndc | 0409-4699-30 |
| ndc | 0409-4699-53 |
| ndc | 0409-4699-33 |
| ndc | 0409-4699-54 |
| ndc | 0409-4699-24 |
| ndc | 0409-6010-02 |
| ndc | 0409-6010-25 |
| ndc | 0409-1511-97 |
| ndc | 0409-1511-98 |
| ndc | 0409-0501-97 |
| ndc | 0409-0501-98 |
| ndc | 0409-0010-97 |
| ndc | 0409-0010-98 |
| code_info | 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…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. |
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-159-2013%22
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