Drug recall: 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…
Class II FDA enforcement event 78110. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection.
Class II, in the words of FDA
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
Amgen, Inc. started this drug recall on 13 Sep 2017. The firm address in the FDA record is in Thousand Oaks, CA. FDA put the recall in Class II. FDA event 78110 has 1 product record. The first FDA enforcement report date is 27 Sep 2017. The record gives the status Terminated, with the termination date 29 Mar 2018.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
U.S.A. Nationwide
Recalling firm
Amgen, Inc., Thousand Oaks, CA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1173-2017 | 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 | 275,380 vials | Class II | Terminated | 27 Sep 2017 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Drug events that started in 2017
- 343
- Share of these events in Class II
- 57%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 7
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 4 Jun 2026 | Corlanor (ivabradine) tablets, 5 mg, packaged in a) 14 tablets bottles (NDC 55513-800-99), and b) 60 tablet bottles (NDC | Drug | Class II | 5 |
| 27 Feb 2025 | Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx Only, For Subcutaneous or Intravenous Use O | Drug | Class II | 2 |
| 2 May 2022 | MVASI (bevacizumab-awwb), Injection, For Intravenous Infusion After Dilution, 100 mg/4 ml, Single dose vial, Rx only, Ma | Drug | Class II | 1 |
| 4 Aug 2017 | Procrit Epoetin Alfa 40,000 units/mL single use vial For Intravenouse or Subcutaneous Use Only, Rx only, Manufactured by | Drug | Class II | 1 |
| 15 Dec 2016 | AMGEN Kyprolis (carfilzomib) for injection, 30 mg per vial, Discard unused portion, For Intravenous Administration Only, | Drug | Class II | 1 |
| 17 Sep 2013 | Prolia (denosumab) Injection, 60 mg/mL, 1 x 60 mg Single Use Prefilled Syringe per carton, Rx only, Manufactured by: Amg | Drug | Class II | 1 |
Official channels
- FDA enforcement report D-1173-2017The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 78110. https://recallregister.com/fda/ii/78110/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
U.S.A. Nationwide
- What quantity of product is in FDA event 78110?
- The FDA record gives this quantity:
275,380 vials
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2017 have the same class?
- 57% of the 343 drug events that started in 2017 are in Class II.