Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusion vial, 200 mg/20 mL...
FDA Recall #D-159-2013 — Class II — November 15, 2012
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.
Recalling Firm
Hospira Inc. — Lake Forest, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
273,925 vials
Distribution
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.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.