FDA recall Z-1010-2018

Product

NaturaLyte¿ Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 3.43 liter bottle This concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

Reason for recall

The label specifies the potassium concentration is 2.0 mEq/L. Some of the product in the affected lot was found to have a potassium concentration of 2.25 mEq/L.

Distribution

US Distribution to states of: CA, FL, KS, LA, and TX.

Key facts

Status

Terminated

Initiation date

2017-09-29

Report date

2018-03-21

Termination date

2018-08-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Waltham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1010-2018