Recall: D-1382-2012

Class II - Potentially Harmful

Class IIClassification

2012-04-11Initiated

TerminatedStatus

Hospira, Inc.Firm

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

Presence of Particulate Matter: A single visible particulate was observed in a retention sample bottles identified as stainless steel

Distribution

Nationwide.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.