Glutathione Inhalation 30mg/ml Solution recall: Sterility Concern
GLUTATHIONE INHALATION 30MG/ML SOLUTION 120 ML, 60 ML; GLUTATHIONE P.F. 200MG/ML INJECTABLE 10 ML, 100 ML, 14 ML, 150 ML, 175 ML, 20 ML, 30 ML, 300…
Why was Glutathione Inhalation 30mg/ml Solution recalled?
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
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?
Rx #'s: 0389833 0394741 0392912 0388244 0397159 0399176 0388244 0405177 0409379 0392912 0397159 0377235 0408837 0402247 0388244 0397159 0403342 0404418 0388244 0393276 0393276 0351537 0393276 0351537 0393276 0390499
- Product
- GLUTATHIONE INHALATION 30MG/ML SOLUTION 120 ML, 60 ML; GLUTATHIONE P.F. 200MG/ML INJECTABLE 10 ML, 100 ML, 14 ML, 150 ML, 175 ML, 20 ML, 30 ML, 300…
- Recalling firm
- Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Quantity
- 47 units
- Distribution
- Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies
- Recall date
- August 22, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)