FDA Drug recall D-297-2013
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, Rx only, Hospira, Inc., Lake Forest, IL 6004…
- FDA Drug
- Class II
- terminated
- Published 2013-05-01
On 2013-05-01 the FDA classified a Class II recall of Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, Rx only, Hospira, Inc., Lake Forest, IL 6004… by Hospira, citing presence of Particulate Matter: A single visible particulate was identified during a retain sample inspection.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-297-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-04-08 |
| Published | 2013-05-01 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Hospira |
| Distribution | US |
Product
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.
Reason
Presence of Particulate Matter: A single visible particulate was identified during a retain sample 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 #: 11-185-DJ*, 11-196-DJ*, Exp 1NOV2013; * 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-297-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.