FDA recall D-0919-2018

Medi-Fare Drug and Home Health Center · Class II · drug

Product

Potassium Chloride For Injection Concentrate syringe 40 mEq/20 mL (2 mEq/mL), Rx only, Medi-Fare Drug Pharmaceutical Compounding 300 West Pine St., Blacksburg, SC 29702 800-622-0007

Reason for recall

CGMP Deviations: Syringes were filled with 19mL of potassium chloride when the labels displayed a fill of 20mL.

Distribution

Texas only

Key facts

Status: Terminated
Initiation date: 2018-07-03
Report date: 2018-07-18
Termination date: 2019-04-03
Voluntary/Mandated: Voluntary: Firm initiated
Location: Blacksburg, SC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0919-2018