FDA Drug recall D-1382-2012
Propofol Injectable Emulsion, 1%, (10mg/mL), packaged in a) 200 mg/20 mL, 5 Units x 20 mL Single patient infusion vials per carton (NDC 040…
- FDA Drug
- Class II
- terminated
- Published 2012-06-20
On 2012-06-20 the FDA classified a Class II recall of Propofol Injectable Emulsion, 1%, (10mg/mL), packaged in a) 200 mg/20 mL, 5 Units x 20 mL Single patient infusion vials per carton (NDC 040… by Hospira, citing presence of Particulate Matter: A single visible particulate was observed in a retention sample bottles identified as stainless steel.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1382-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-04-11 |
| Published | 2012-06-20 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Hospira |
| Distribution | US |
Product
Propofol Injectable Emulsion, 1%, (10mg/mL), packaged in a) 200 mg/20 mL, 5 Units x 20 mL Single patient infusion vials per carton (NDC 0409-4699-30); b) 1 g/100 mL, 10 Units x 100 mL Single patient infusion vials per carton (NDC 0409-4699-24); Rx only, Hospira, Inc., Lake Forest, IL 60045, USA.
Reason
Presence of Particulate Matter: A single visible particulate was observed in a retention sample bottles identified as stainless steel
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) 03440DJ*, Exp 1MAR2013; b) 07947DJ, Exp 1JUL2013; 10134DJ, Exp 1OCT2013; Note: * the lot 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-1382-2012%22
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