FDAClass IIMay 24, 2017

Glutathione INH *pv* 200mg/ml Soln recall: Sterility Concern

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

Why was Glutathione INH *pv* 200mg/ml Soln recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 02-20-2017@8, Exp 4/21/2017.

Product
GLUTATHIONE INH *PV* 200MG/ML SOLN, Inhalation Solution, 200mg/mL, Rx only, 4mL Plastic/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Recalling firm
Key Pharmacy and Compounding Center
Quantity
240 mL
Distribution
Distributed nationwide in U.S.A., Australia and Canada.
Recall date
May 24, 2017
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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