FDA recall D-0553-2020

QuVa Pharma, Inc. · Class II · drug

Product

fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1093-37

Reason for recall

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

Distribution

Nationwide.

Key facts

Status: Terminated
Initiation date: 2019-11-12
Report date: 2019-12-11
Termination date: 2020-06-05
Voluntary/Mandated: Voluntary: Firm initiated
Location: Sugar Land, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0553-2020