Propofol Injectable Emulsion — Class I drug recall D-1547-2014
Terminated recall by Hospira Inc., reported 2014-08-27, distributed nationwide. Presence of Particulate Matter: A glass defect was found on the interior neck of the vial during a retain samp
| Recall number | D-1547-2014 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2014-04-02 |
| Classified | 2014-08-20 |
| Reported by FDA | 2014-08-27 |
| Terminated | 2015-05-29 |
| Distributed | Nationwide (US) |
| Quantity | 844,300 vials |
| Reason classes | foreign material, 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 |
| Lot numbers | 29-614-DJ, 29-615-DJ, 29-616-DJ, 29-617-DJ, 29-628-DJ, 29-629-DJ, 29-630-DJ |
| Expiration dates | 2015-05-01 |
Product
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), For I.V. Administration, Rx Only, 20 mL vial, Contains Benzyl Alcohol, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4699-30
Reason for recall
Presence of Particulate Matter: A glass defect was found on the interior neck of the vial during a retain sample inspection where the glass vial contained visible embedded metallic particulate and free floating metallic particulates were also found in solution.
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-1547-2014. 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.