| Recall Number | D-1382-2012 |
|---|---|
| Recalling Firm | Hospira, Inc. |
| Classification | Class II |
| Voluntary / Mandated | Voluntary: Firm initiated |
| Distribution Pattern | Nationwide. |
| Status | Terminated |
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.
Presence of Particulate Matter: A single visible particulate was observed in a retention sample bottles identified as stainless steel
Lot #: a) 03440DJ*, Exp 1MAR2013; b) 07947DJ, Exp 1JUL2013; 10134DJ, Exp 1OCT2013; Note: * the lot may be followed by 01.