Shire Recalls Kalbitor Due to Presence of Glass Particulate Matter
Shire is recalling specific lots of Kalbitor (ecallantide) injection because glass particles were found in the product.
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 recall is classified as FDA Class II, and the presence of glass particulate matter in a subcutaneous injectable drug poses a significant risk of injury, meeting the criteria for a Severe rating.
Plain-English summary
Shire is voluntarily recalling 3,536 cartons of Kalbitor (ecallantide), 10mg/mL, packaged in 3 vials per carton. The recall is due to the presence of particulate matter, specifically glass, in the product. The affected lot number is A1500009, with an expiration date of January 31, 2019.
The recalled product was distributed nationwide and in Kuwait. Kalbitor is a prescription medication administered via subcutaneous injection. The presence of glass particles in an injectable medication poses a risk of injury to patients.
Patients and healthcare providers should stop using the affected lot of Kalbitor and contact their healthcare provider or Shire for further instructions. Consumers should check their medication packaging for the lot number A1500009 and expiration date of January 31, 2019, to determine if they have the affected product.
The recalled product
- Product
- KALBITOR (ECALLANTIDE)
- Brand
- KALBITOR
- Manufacturer
- Shire
- Category
- Drug — Prescription Injection
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 #: A1500009
- Exp. Jan 31
- 2019
Distribution
Distributed nationwide across the United States.
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