Class II · Moderate risk
Procrit (epoetin alfa)
Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection.
Procrit (epoetin alfa)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of Particulate Matter: glass delamination
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
Procrit (epoetin alfa) injection, 20000 units/mL, 4 mL vial; Mfg By: Amgen Inc., Thousand Oaks, CA 91320; Dist. By: Physicians Total Care, Tulsa, OK 74146; NDC 54868-5673-1.
Affected NDC
54868-5673-01
Compare with the code on your package — it is the most precise check available.
Drug: Epoetin
- Recalling firm
- Physicians Total Care, Inc.
- NDC code
- 54868-5673-1
- Origin
- OK, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-093-2013 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Epoetin recalls
See all
Class II · Moderate risk
Procrit Epoetin Alfa 40
Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials.
Other recalls by Physicians Total Care, Inc.
All 2010 recalls
Class II · Moderate risk
Cephalexin Monohydrate Capsules
CGMP deviations: Products were manufactured with active pharmaceutical ingredients that were not manufactured with good manufacturing practices.
Class II · Moderate risk
Carisoprodol IV
Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing.
Class III · Low risk
Loratadine 24 HR-OTC
Failed Tablet/Capsule Specifications: Affected lot numbers may contain chipped or broken tablets.
Class II · Moderate risk
Belladonna Alkaloids/PB
Presence of Foriegn Substance:The manufacturer, West-ward Pharmaceutical, recalled product because of the presence of black spots on tablets. In response, the repackager initiated its own recall.
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