The Recall Desk
SevereFDA (Drugs)·D-0389-2015·Announced 2015-02-25

Hospira Recalls Propofol Injectable Emulsion Due to Temperature Excursions

Hospira Inc. is recalling 2,500 vials of Propofol Injectable Emulsion because the products experienced uncontrolled temperature excursions during transit.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.

Plain-English summary

Hospira Inc. is recalling 2,500 vials of Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vials. The recall is due to temperature abuse, where the products experienced uncontrolled temperature excursions during transit.

The affected product is identified by Lot # 33-750-DJ with an expiration date of 1SEP2015. The distribution was limited to one shipment to The Harvard Drug Group in Livonia, MI. According to the source, these lots remained within the control of the distributor and were not further distributed.

Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If found, the product should be quarantined and not used. For further information, contact the recalling firm or the FDA.

The recalled product

Product
PROPOFOL (PROPOFOL)
Brand
PROPOFOL
Manufacturer
Hospira Inc.
Affected units
2,500

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • One shipment of Lot #: 33-750-DJ
  • Exp 1SEP2015 to The Harvard Drug Group
  • Livonia
  • MI

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Hospira Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →