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…
Reason Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection.
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials.
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
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection.
Reason Presence of Particulate Matter: glass delamination
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