Hospira Recalls Propofol Vials Due to Glass Particulate Matter
Hospira is recalling 126,425 vials of Propofol Injectable Emulsion due to a glass defect that could release particulate matter into the solution.
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 and involves a structural defect in the vial that could introduce particulate matter into an intravenous solution, posing a significant risk of injury.
Plain-English summary
Hospira Inc. is recalling 126,425 vials of Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial. The product is identified by Lot # 27-568-DJ* (where * may be followed by 01) and has an expiration date of 03/15. The recall is classified as FDA Class II.
The recall is being issued because of a glass defect located on the interior neck of the vial. This defect resulted in glass surface abrasions and visible embedded particulate matter, which creates a potential for small glass flakes or embedded metal particulate to become dislodged into the solution.
The affected product was distributed nationwide. Healthcare providers and facilities should stop using the affected vials and contact Hospira for further instructions.
The recalled product
- Product
- PROPOFOL (PROPOFOL)
- Brand
- PROPOFOL
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injectable Anesthetic
- Affected units
- 126,425
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 (3)
- Lot #: 27-568-DJ*
- Exp 03/15
- Note * may be followed by 01
Distribution
Distributed nationwide across the United States.
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