FDA-Drug2019-12-11Class II

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

QuVa Pharma, Inc.
Hazard

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Sold states
Nationwide.
Manufactured in
1075 W Park One Dr Ste 100, Sugar Land, TX, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0547-2020

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