FDA recall D-1606-2014

Product

Potassium Chloride Injection, 10 mEq per 100 mL, Highly Concentrated (100 mEq/L), 100 mL Sterile single dose container bags, Rx only, Baxter USA, product code 2B0826, NDC 0338-0709-48.

Reason for recall

Correct Labeled Product Mispack: Shipping cartons labeled as containing Potassium Chloride injection actually contained bags labeled and containing Gentamicin Sulfate injection inside.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2014-09-08

Report date

2014-10-01

Termination date

2016-09-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1606-2014