Propofol Injectable Emulsion — Class II drug recall D-1382-2012
Terminated recall by Hospira, Inc., reported 2012-06-20, distributed nationwide. Presence of Particulate Matter: A single visible particulate was observed in a retention sample bottles identi
| Recall number | D-1382-2012 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira, Inc., Lake Forest, IL, United States |
| Recall initiated | 2012-04-11 |
| Classified | 2012-06-14 |
| Reported by FDA | 2012-06-20 |
| Terminated | 2013-06-27 |
| Distributed | Nationwide (US) |
| 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 | 2013-03-01, 2013-07-01, 2013-10-01 |
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 for recall
Presence of Particulate Matter: A single visible particulate was observed in a retention sample bottles identified as stainless steel
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-1382-2012. 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.