QuVa Pharma, Inc. recalls fentaNYL 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.1% 200 mg/200 mL (1 mg/mL) in 0.9% Sodium Chloride 200 mL CADD, Pr…
- Recall date
- November 12, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0564-2020
- 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 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.1% 200 mg/200 mL (1 mg/mL) in 0.9% Sodium Chloride 200 mL CADD, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1441-76
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