D-1382-2012 Class II Terminated
FDA drug recall D-1382-2012 was initiated by Hospira, Inc. on Apr 11, 2012 and is designated Class II. Reason for recall: Presence of Particulate Matter: A single visible particulate was observed in a retention sample bottles identified as stainless steel The recall status is terminated (terminated Jun 27, 2013). Affected quantity: a) 36,125 vials; b) 31,280 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 20, 2012
- Initiation Date
- Apr 11, 2012
- Termination Date
- Jun 27, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 36,125 vials; b) 31,280 vials
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
Distribution Pattern
Nationwide.
Code Information
Lot #: a) 03440DJ*, Exp 1MAR2013; b) 07947DJ, Exp 1JUL2013; 10134DJ, Exp 1OCT2013; Note: * the lot may be followed by 01.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1382-2012
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026