Amgen Recalls Procrit Erythropoietin Vials Due to Glass Particulate Matter
Amgen is recalling specific lots of Procrit (epoetin alfa) vials because glass flakes were found during routine quality inspection.
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 presence of glass particulate matter in an injectable drug poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Amgen, Inc. is recalling 275,380 vials of Procrit (epoetin alfa), 10,000 units/mL, distributed nationwide in the United States. The recall involves two specific lots: G290530A and G290531A, both with an expiration date of 07/18. The product is packaged in boxes of 6 or 25 single-use 1 mL vials.
The recall was initiated after glass flakes, identified as lamellae, were observed during a routine quality inspection. This particulate matter presents a potential risk to patients receiving the medication via intravenous or subcutaneous routes.
Healthcare providers and patients should stop using the affected lots immediately. Amgen is the recalling firm, and the product was manufactured for Janssen Products, LP.
The recalled product
- Product
- PROCRIT (ERYTHROPOIETIN)
- Brand
- PROCRIT
- Manufacturer
- Amgen, Inc.
- Category
- Drug — Prescription Injectable
- Affected units
- 275,380
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 #: a) G290530A
- Exp 07/18
- b) G290531A
Distribution
Distributed nationwide across the United States.
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