Hospira Inc.: 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

Is my product affected?

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,

• Brand PROPOFOL

Check against the official notice below — it lists the full affected range.

What happened

Hospira Inc. is recalling Propofol Injectable Emulsion, 1%, in 20 mL and 50 mL single patient infusion vials distributed nationwide. The recall affects 148,630 vials across multiple lot numbers with expiration dates ranging from January 2013 to September 2012. The reason for the recall is the presence of particulate matter—a single visible particulate was observed and confirmed in sample bottles during retain inspection.

The affected lot numbers are: 93-857-DJ, 93-896-DJ, 04-515-DJ, 06-802-DJ (for 20 mL vials); 01-175-DJ, 04-565-DJ (for 50 mL vials); and 03-388-DJ (for an additional vial size). Lot numbers may be followed by 01 or 02. The source does not specify a remedy for consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Presence of Particulate Matter: A single visible particulate was observed and confirmed in sample bottles of the recalled lots during retain inspection.

Details from the source

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: Nationwide Quantity: 148,630 vials Lot/code info: 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

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• 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, 2012-11-15
• Propofol Injectible Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, packaged in 5 Units x 20 mL per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.2013-12-12
• Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), For I.V. Administration, Rx Only, 20 mL vial, Contains Benzyl Alcohol, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4699-302014-04-02
• Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vials, packaged in 5 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.2014-10-06
• Ventolin HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation, 200 Metered Inhalations, FOR ORAL INHALATION ONLY - For use with Ventolin HFA actuator only. Net. wt. 18 g Rx only, GlaxoSmithKline, Reasearch Triangle Park, NC 27709 NDC 0173-0682-202012-07-26

All FDA (Drug enforcement) recalls