FDA recall D-0076-2021

Product

Bupivacaine Hydrochloride in 8.25% Dextrose Injection, USP Spinal 0.75% (15 mg/2 mL) 10 x 2 mL single-dose ampules, Rx only, Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA, Manufactured by: Baxter Pharmaceuticals India Private Ltd Ahmedabad 382213 India, NDC 36000-092-10

Reason for recall

Presence of particulate matter in solution - black and transparent particles

Distribution

Nationwide USA

Key facts

Status

Terminated

Initiation date

2020-10-07

Report date

2020-11-18

Termination date

2023-05-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0076-2021