Amgen Recalls Kyprolis Vials Due to Potential Glass Cracks
Amgen is recalling 11,434 vials of Kyprolis (carfilzomib) injection because potential cracks in the glass vials may compromise sterility.
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. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects (glass cracks compromising sterility) are rated Severe (4).
Plain-English summary
Amgen, Inc. is recalling 11,434 vials of Kyprolis (carfilzomib) for injection, 30 mg per vial. The recall is due to a lack of assurance of sterility caused by potential cracks in the glass vials.
The affected product is identified by Lot #1071559 and #1071629, with an expiration date of 05/18. The product was distributed in the United States and Puerto Rico. No foreign distribution occurred.
Healthcare providers and patients should stop using the affected vials and contact Amgen or their healthcare provider for further instructions.
The recalled product
- Product
- KYPROLIS (CARFILZOMIB)
- Brand
- KYPROLIS
- Manufacturer
- Amgen, Inc.
- Category
- Drug — Prescription Injection
- Hazard
- Affected units
- 11,434
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 #1071559
- 1071629
- Exp. 05/18
Distribution
Distributed in 1 state:
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