PlainRecalls
FDA Drug Moderate Class II Terminated

L-Glutathione 200 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183

Reported: September 25, 2013 Initiated: August 23, 2013 #D-1051-2013

Product Description

L-Glutathione 200 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183

Reason for Recall

Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.

Details

Recalling Firm
Medaus, Inc.
Units Affected
6130 mL
Distribution
Nationwide
Location
Birmingham, AL

Frequently Asked Questions

What product was recalled?
L-Glutathione 200 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183. Recalled by Medaus, Inc.. Units affected: 6130 mL.
Why was this product recalled?
Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.
Which agency issued this recall?
This recall was issued by the FDA Drug on September 25, 2013. Severity: Moderate. Recall number: D-1051-2013.