The Recall Desk
SevereFDA (Drugs)·D-66637-001·Announced 2013-11-13

Hospira Recalls Propofol Injectable Emulsion Due to Particulate Matter

Hospira Inc. is recalling 70,450 vials of Propofol Injectable Emulsion because visible particles were found in the glass during inspection.

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 recall is classified as FDA Class II, which corresponds to a severity score of 4 (Severe) according to the rubric, as it may cause temporary or medically reversible adverse health consequences.

Plain-English summary

Hospira Inc. is recalling 70,450 vials of Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL single patient infusion vials. The product is identified by Lot # 27-570-DJ and has an expiration date of 03/01/15. The recall was initiated because visible particles embedded in the glass were identified during a retain sample inspection.

The affected product is distributed nationwide. It is a prescription-only medication used for general anesthesia. The recall is classified as FDA Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Healthcare facilities and pharmacies should stop using the affected product and contact Hospira Inc. for further instructions. Consumers should not use the product and should return it to the point of purchase or contact their healthcare provider.

The recalled product

Product
PROPOFOL (PROPOFOL)
Brand
PROPOFOL
Manufacturer
Hospira Inc.
Affected units
70,450

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 (2)

  • Lot #: 27-570-DJ
  • Exp 03/01/15

Distribution

Distributed nationwide across the United States.