Fentanyl Citrate 50 mcg/ml injection recalled over sterility concerns
- Recall date
- April 20, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Pharmakon Pharmaceuticals, Inc. recalls Fentanyl Citrate 50 mcg/ml injection, 2mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Nob…
- Recall number
- D-1259-2016
- FDA classification
- Class II
- Brand / firm
- Pharmakon Pharmaceuticals, Inc.
- Sold / distributed
- Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA
Why it was recalled
Lack of Assurance of Sterility
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Fentanyl Citrate 50 mcg/ml injection, 2mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0100-69
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