QuVa Pharma, Inc. recalls fentaNYL 500 mcg/250 mL (2 mcg/mL) 0.125% BUPivacaine HCl 312.5 mg/250 mL (1.25 mg/mL) in 0.9% Sodium Chloride 250 mL Ba
Recalled December 11, 2019 · FDA recall D-0547-2020 · 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) 0.125% BUPivacaine HCl 312.5 mg/250 mL (1.25 mg/mL) in 0.9% Sodium Chloride 250 mL Bag, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1105-37
Manufacturer(s)
QuVa Pharma, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →