Amgen Recalls Prolia Injection Due to Visible Cellulose Fibers
Amgen is recalling 4,163 Prolia (denosumab) prefilled syringes because visible cellulose fibers were found during routine quality checks.
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, which corresponds to a 'Severe' severity score under the rubric, as it may cause temporary or medically reversible adverse health consequences.
Plain-English summary
Amgen, Inc. is recalling 4,163 prefilled syringes of Prolia (denosumab) Injection, 60 mg/mL. The recall affects Lot #1037592, which has an expiration date of 07/15. The product is distributed nationwide, in Puerto Rico, Canada, Mexico, and through clinical distribution in Europe.
The recall was initiated because visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Healthcare providers and patients should stop using the affected syringes and contact Amgen or their local FDA office for further instructions. Consumers should check their medication packaging for the specific lot number and expiration date listed above to determine if they are affected.
The recalled product
- Product
- PROLIA (DENOSUMAB)
- Brand
- PROLIA
- Manufacturer
- Amgen, Inc.
- Category
- Drug — Prescription Injection
- Affected units
- 4,163
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 #: 1037592
- Exp 07/15
UPCs (1)
- 355513710015
Distribution
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