FDA recall D-0546-2020

Product

fentaNYL 500 mcg/250 mL (2 mcg/mL) Bupivacaine HCl 0.1% 250 mg/250 mL (1 mg/mL) in 0.9% Sodium Chloride 250 mL Bag, Rx only, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1160-37

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-0546-2020