QuVa Pharma, Inc. recalls fentaNYL 500 mcg/250 mL (2 mcg/mL) ROPivacaine HCl 0.2% 500 mg/250 mL (2 mg/mL) in 0.9% Sodium Chloride 250 mL Bag Rx, P
Recalled December 11, 2019 · FDA recall D-0552-2020 · 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 500 mcg/250 mL (2 mcg/mL) ROPivacaine HCl 0.2% 500 mg/250 mL (2 mg/mL) in 0.9% Sodium Chloride 250 mL Bag Rx, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1225-37
Manufacturer(s)
QuVa Pharma, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →