The Recall Desk
HighFDA (Drugs)·D-1173-2017·Announced 2017-09-27

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.

What this means for you

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
Hazard
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.

Related recalls

Same brand · PROCRIT

Same manufacturer · Amgen, Inc.

See all →

Same hazard · particulate matter

See all →