QuVa Pharma, Inc. recalls fentaNYL 800 mcg/200 mL (4 mcg/mL) BUPivacaine HCl 0.1667% 333.4 mg/200 mL (1.667 mg/mL) in 0.9% Sodium Chloride 200 mL
Recalled December 11, 2019 · FDA recall D-0568-2020 · QuVa Pharma
Hazard
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules · FDA Class II
Sold at
Nationwide.
Description
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Product
fentaNYL 800 mcg/200 mL (4 mcg/mL) BUPivacaine HCl 0.1667% 333.4 mg/200 mL (1.667 mg/mL) in 0.9% Sodium Chloride 200 mL in 250 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1436-76
Manufacturer(s)
QuVa Pharma, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →