D-1685-2012 Class II Terminated
FDA drug recall D-1685-2012 was initiated by Hospira Inc. on Aug 29, 2012 and is designated Class II. Reason for recall: Presence of Particulate Matter: A single visible particulate was observed and confirmed in sample bottles of the recalled lots during retain inspection. The recall status is terminated (terminated Aug 8, 2013). Affected quantity: 148,630 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 3, 2012
- Initiation Date
- Aug 29, 2012
- Termination Date
- Aug 8, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 148,630 vials
Product Description
Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusion vial, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 50 mL Single patient infusion vial, 500 mg/50 mL (10 mg/mL), NDC 0409-4699-33; c) 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
Reason for Recall
Presence of Particulate Matter: A single visible particulate was observed and confirmed in sample bottles of the recalled lots during retain inspection.
Distribution Pattern
Nationwide
Code Information
Lot No: a) 93-857-DJ, 93-896-DJ, Exp 1SEP2012; 04-515-DJ, Exp 1APR2013; 06-802-DJ, Exp 1JUN2013; b) 01-175-DJ, Exp 1JAN2013; 04-565-DJ, Exp 1APR2013; c) 03-388-DJ, Exp 1MAR2013; The lot number may be followed by 01 or 02
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1685-2012
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026