PlainRecalls
FDA Drug Moderate Class II Terminated

Gentamicin buffered 36.4 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907

Reported: July 10, 2013 Initiated: March 20, 2013 #D-642-2013

Product Description

Gentamicin buffered 36.4 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907

Reason for Recall

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Details

Units Affected
35ml total
Distribution
FL, GA and SC.
Location
Augusta, GA

Frequently Asked Questions

What product was recalled?
Gentamicin buffered 36.4 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907. Recalled by Clinical Specialties Compounding Pharmacy. Units affected: 35ml total.
Why was this product recalled?
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Which agency issued this recall?
This recall was issued by the FDA Drug on July 10, 2013. Severity: Moderate. Recall number: D-642-2013.