PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: July 18, 2018 Initiated: July 3, 2018 #D-0919-2018

Product Description

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.

Details

Units Affected
1116 syringes
Distribution
Texas only
Location
Blacksburg, SC

Frequently Asked Questions

What product was recalled?
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. Recalled by Medi-Fare Drug and Home Health Center. Units affected: 1116 syringes.
Why was this product recalled?
CGMP Deviations: Syringes were filled with 19mL of potassium chloride when the labels displayed a fill of 20mL.
Which agency issued this recall?
This recall was issued by the FDA Drug on July 18, 2018. Severity: Moderate. Recall number: D-0919-2018.