FDA recall D-0767-2021

Product

Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903 NDC 70324-326-01

Reason for recall

Non-Sterility: firm's third party lab confirmed microbial contamination.

Distribution

Nationwide in the US

Key facts

Status

Terminated

Initiation date

2021-08-10

Report date

2021-09-01

Termination date

2022-05-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Plattsburgh, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0767-2021