Amgen Recalls Procrit Erythropoietin Vials Due to Visible Glass Flakes
Amgen is recalling 175,632 vials of Procrit (Erythropoietin) because visible glass flakes were identified in some drug product vials.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves visible particulate matter (glass flakes) in an injectable drug, which poses a risk of harm even though specific injury reports are not detailed in the source text.
Plain-English summary
Amgen, Inc. is recalling 175,632 vials of Procrit (Erythropoietin) 40,000 units/mL single-use vials. The recall is due to the presence of particulate matter, specifically visible glass flakes identified as lamellae, in some of the drug product vials.
The affected product is a prescription drug manufactured by Amgen, Inc., and manufactured for Janssen Products, LP. The specific lots involved are G290491A and G290491B, with an expiration date of 06/18. The product was distributed in the United States, including Puerto Rico.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recalled description, it should not be used. Patients should contact their healthcare provider for guidance on alternative treatment options if they have been using the affected product.
The recalled product
- Product
- PROCRIT (ERYTHROPOIETIN)
- Brand
- PROCRIT
- Manufacturer
- Amgen, Inc.
- Category
- Drug — Prescription Injectable
- Affected units
- 175,632
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 #: G290491A
- G290491B
- Exp. 06/18
Distribution
Distributed in 1 state:
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