FDA recall D-0399-2024

Product

fentaNYL 100 mcg/50 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT 06095, NDC 70004-0231-22, Bar Code 70004023122

Reason for recall

Lack of Assurance of Sterility

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2023-11-09

Report date

2024-04-03

Termination date

2024-08-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Windsor, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0399-2024