FDA Drug recall D-1685-2012
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 2012-10-03
On 2012-10-03 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: A single visible particulate was observed and confirmed in sample bottles of the recalled lots during retain inspection.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1685-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-08-29 |
| Published | 2012-10-03 |
| 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: A single visible particulate was observed and confirmed in sample bottles of the recalled lots 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 No: a) 93-857-DJ, 93-896-DJ, Exp 1SEP2012; 04-515-DJ, Exp 1APR2013; 06-802-DJ, Exp 1JUN2013; b) 01-175-DJ, Exp 1JAN…Lot No: a) 93-857-DJ, 93-896-DJ, Exp 1SEP2012; 04-515-DJ, Exp 1APR2013; 06-802-DJ, Exp 1JUN2013; b) 01-175-DJ, Exp 1JAN2013; 04-565-DJ, Exp 1APR2013; c) 03-388-DJ, Exp 1MAR2013; The lot number may be followed by 01 or 02 |
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-1685-2012%22
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