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.
Reported: June 20, 2012 Initiated: April 11, 2012 #D-1382-2012
Product Description
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
Details
- Recalling Firm
- Hospira, Inc.
- Units Affected
- a) 36,125 vials; b) 31,280 vials
- Distribution
- Nationwide.
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Hospira, Inc.. Units affected: a) 36,125 vials; b) 31,280 vials.
Why was this product recalled? ▼
Presence of Particulate Matter: A single visible particulate was observed in a retention sample bottles identified as stainless steel
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 20, 2012. Severity: Moderate. Recall number: D-1382-2012.
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