Propofol Injectable Emulsion — Class II drug recall D-1685-2012
Terminated recall by Hospira Inc., reported 2012-10-03, distributed nationwide. Presence of Particulate Matter: A single visible particulate was observed and confirmed in sample bottles of t
| Recall number | D-1685-2012 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2012-08-29 |
| Classified | 2012-09-21 |
| Reported by FDA | 2012-10-03 |
| Terminated | 2013-08-08 |
| Distributed | Nationwide (US) |
| Quantity | 148,630 vials |
| Reason classes | specification failure |
| NDC | 00409-0010, 00409-0010-97, 00409-0010-98, 00409-0501, 00409-0501-97, 00409-0501-98, 00409-1511, 00409-1511-97, 00409-1511-98, 00409-4699, 00409-4699-24, 00409-4699-30, 00409-4699-33, 00409-4699-50, 00409-4699-53, 00409-4699-54, 00409-6010, 00409-6010-02, 00409-6010-25 |
| Expiration dates | 2012-09-01, 2013-01-01, 2013-03-01, 2013-04-01, 2013-06-01 |
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 for recall
Presence of Particulate Matter: A single visible particulate was observed and confirmed in sample bottles of the recalled lots during retain inspection.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1685-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.