QuVa Pharma, Inc. recalls fentaNYL 2000 mcg/100 mL (20 mcg/mL) in 0.9% Sodium Chloride, 100 mL Bag, Preservative Free, Rx, QuVA Pharma 1075 West…
- Recall date
- November 12, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0563-2020
- FDA classification
- Class II
- Brand / firm
- QuVa Pharma, Inc.
- Sold / distributed
- Nationwide.
Why it was recalled
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
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 2000 mcg/100 mL (20 mcg/mL) in 0.9% Sodium Chloride, 100 mL Bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1094-36
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