Reported Oct 3, 2012 · Terminated
Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusion vial, 200 mg/20 mL (10 mg/mL), NDC…
Hospira Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hospira Inc. · 275 N Field Dr · Lake Forest, IL · 60045-2579
Is this the product you have?
3 of 3 products
| # | Product as published |
|---|---|
| 1 | 20 mL Single patient infusion vial, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30 |
| 2 | 50 mL Single patient infusion vial, 500 mg/50 mL (10 mg/mL), NDC 0409-4699-33 |
| 3 | 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 |
- Lot codes and dates
3 of 3 products
Products covered by this recall # Product as published 1 93-857-DJ, 93-896-DJ, Exp 1SEP2012; 04-515-DJ, Exp 1APR2013; 06-802-DJ, Exp 1JUN2013 2 01-175-DJ, Exp 1JAN2013; 04-565-DJ, Exp 1APR2013 3 03-388-DJ, Exp 1MAR2013; The lot number may be followed by 01 or 02 - Amount recalled
- 148,630 vials
Where it was sold
- Nationwide
Why it was recalled
Presence of Particulate Matter: A single visible particulate was observed and confirmed in sample bottles of the recalled lots during retain inspection.
This product could cause temporary or reversible health problems — stop using it.
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