Procrit Injection, Solution
FDA Recall NDC 59676-310
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Procrit (NDC 59676-310). A significant event, classified as Class II, was initiated on Sep 13, 2017 by Janssen Products, Lp. The reported reason for this action was: "Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection.
Sep 13, 2017
Sep 27, 2017
275,380 vials
Recall Profile & Regulatory Data
Event ID
78110
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Amgen, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S.A. Nationwide
Termination Date
Mar 29, 2018
Product Description
Procrit (epoetin alfa), 10,000 units/mL, packaged in a) box of 6 single use 1 mL vials (NDC 59676-310-01), b) box of 25 single use 1 mL vials (NDC 59676-310-02), Rx Only, Manufactured by: Amgen, Inc. Thousand Oaks, CA 91320, Manufactured for: Janssen Products, LP Horsham, PA 19044
Batch or Lot Expiration Information
Lot# : a) G290530A, Exp 07/18; b) G290531A, Exp 07/18
Affected Packages Involved in this Recall
59676-303-00Product
59676-303-01Product
59676-304-00Product
59676-304-01Product
59676-310-00Product
59676-310-01Product
59676-310-02Product
59676-302-00Product
59676-302-01Product
59676-340-00Product
59676-340-01Product
59676-312-00Product
59676-312-04Product
59676-320-00Product
59676-320-04Product
Class II Terminated
Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials.
Aug 04, 2017
Aug 23, 2017
175,632 vials
Recall Profile & Regulatory Data
Event ID
77889
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Amgen, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
United States including Puerto Rico
Termination Date
Mar 29, 2018
Product Description
Procrit Epoetin Alfa 40,000 units/mL single use vial For Intravenouse or Subcutaneous Use Only, Rx only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320-1799, Manufactured for: Janssen Products, LP Horsham, PA 19044, NDC 59676-340-01
Batch or Lot Expiration Information
Lot# : G290491A, G290491B, Exp. 06/18
Affected Packages Involved in this Recall
59676-303-00Product
59676-303-01Product
59676-304-00Product
59676-304-01Product
59676-310-00Product
59676-310-01Product
59676-310-02Product
59676-302-00Product
59676-302-01Product
59676-340-00Product
59676-340-01Product
59676-312-00Product
59676-312-04Product
59676-320-00Product
59676-320-04Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
