Fentanyl Citrate 5 mcg/mL & Bupivacaine 0 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 5 mcg/mL & Bupivacaine 0.06% in 0.9% Sodium Chloride, 60 mL BD Syringe, Rx Only, Compounded by PHARMAK…
- Recall number
- D-1310-2016
- 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 5 mcg/mL & Bupivacaine 0.06% in 0.9% Sodium Chloride, 60 mL BD Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0827-77
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