D-159-2013 Class II Terminated
FDA drug recall D-159-2013 was initiated by Hospira Inc. on Nov 15, 2012 and is designated Class II. Reason for recall: Presence of Particulate Matter: Visible particulate and particulate embedded in vials were observed during retain inspection. The recall status is terminated (terminated Feb 27, 2014). Affected quantity: 273,925 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 20, 2013
- Initiation Date
- Nov 15, 2012
- Termination Date
- Feb 27, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 273,925 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: Visible particulate and particulate embedded in vials were observed during retain inspection.
Distribution Pattern
Nationwide
Code Information
Lot #: a) 95-070-DJ, Exp 11/01/12; 04-584-DJ, 04-652-DJ, Exp 04/01/13; 05-718-DJ, Exp 05/01/13; 06-815-DJ, Exp 06/01/13; b) 04-525-DJ, 04-530-DJ, 04-641-DJ-04-646-DJ, Exp 04/01/13; c) 02-291-DJ, Exp 02/01/13; 05-725-DJ, 05-732-DJ, Exp 05/01/13; 07-925-DJ, Exp 07/01/13; 09-065-DJ, Exp 09/01/13; 10-129-DJ, 10-133-DJ, 10-148-DJ, Exp 10/01/13, Note lot number 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-159-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026