FentaNYL 2500 mcg/ Injectable Solution recalled over sterility concerns
- Recall date
- March 13, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Advanced Pharma Inc. recalls fentaNYL 2500 mcg/250 mL Injectable Solution, Fentanyl 0.9% Sodium Chloride, QS, Sterile single use bags, NDC: 42852-21…
- Recall number
- D-1018-2019
- FDA classification
- Class II
- Brand / firm
- Advanced Pharma Inc.
- Sold / distributed
- Nationwide
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 2500 mcg/250 mL Injectable Solution, Fentanyl 0.9% Sodium Chloride, QS, Sterile single use bags, NDC: 42852-210-25 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
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