PlainRecalls
FDA Drug Moderate Class II Terminated

GLUTATHIONE INH *PV* 200MG/ML SOLN, Inhalation Solution, 200mg/mL, Rx only, 4mL Plastic/Multiple Dose vial, Prepared by Key Compounding Pharmacy

Reported: May 24, 2017 Initiated: April 18, 2017 #D-0765-2017

Product Description

GLUTATHIONE INH *PV* 200MG/ML SOLN, Inhalation Solution, 200mg/mL, Rx only, 4mL Plastic/Multiple Dose vial, Prepared by Key Compounding Pharmacy

Reason for Recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Details

Units Affected
240 mL
Distribution
Distributed nationwide in U.S.A., Australia and Canada.
Location
Federal Way, WA

Frequently Asked Questions

What product was recalled?
GLUTATHIONE INH *PV* 200MG/ML SOLN, Inhalation Solution, 200mg/mL, Rx only, 4mL Plastic/Multiple Dose vial, Prepared by Key Compounding Pharmacy. Recalled by Key Pharmacy and Compounding Center. Units affected: 240 mL.
Why was this product recalled?
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 24, 2017. Severity: Moderate. Recall number: D-0765-2017.