PlainRecalls
FDA Drug Moderate Class II Terminated

Gentamycin 80mg/1000cc 0.9% NS

Reported: March 12, 2014 Initiated: November 1, 2013 #D-1115-2014

Product Description

Gentamycin 80mg/1000cc 0.9% NS

Reason for Recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Details

Distribution
NC
Location
Asheville, NC

Frequently Asked Questions

What product was recalled?
Gentamycin 80mg/1000cc 0.9% NS. Recalled by Natures Pharmacy & Compounding Center.
Why was this product recalled?
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 12, 2014. Severity: Moderate. Recall number: D-1115-2014.