Hospira Recalls Propofol Injectable Vials Due to Embedded Particulate Matter
Hospira Inc. is recalling 126,075 vials of Propofol Injectable Emulsion because a complaint reported an embedded iron particulate in one vial.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential injury or significant product defects like particulate matter in injectable drugs.
Plain-English summary
Hospira Inc. is recalling 126,075 vials of Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10mg/mL), single patient infusion vials containing benzyl alcohol. The affected product is identified by Lot 35-844-DJ with an expiration date of 11/01/2015. The recall was initiated after the firm received a complaint regarding an embedded particulate in the neck of one vial, which was composed primarily of iron.
The FDA has classified this recall as Class II, indicating a situation in which use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The product was distributed nationwide.
Healthcare providers and facilities should stop using the affected vials and contact Hospira Inc. for further instructions. Patients should consult their healthcare providers if they have questions regarding the use of this medication.
The recalled product
- Product
- PROPOFOL (PROPOFOL)
- Brand
- PROPOFOL
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injectable Anesthetic
- Affected units
- 126,075
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 35-844-DJ
- Exp 11/01/2015
Distribution
Distributed nationwide across the United States.
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