Agency classClass IIOur severity:Severe FDA (Drugs)·D-1529-2012·Announced 2012-08-22

Franck's Lab Recalls Sterile Human Drugs Due to Microbial Contamination

Franck's Lab Inc. is recalling sterile glutathione products distributed between November 2011 and May 2012 because FDA testing found microorganisms and fungal growth in the clean room.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves sterile injectable drugs contaminated with microorganisms and fungal growth, which presents a significant risk of serious injury or infection.

Plain-English summary

Franck's Lab Inc., d.b.a. Franck's Compounding Lab, is recalling 47 units of sterile human drugs, specifically various formulations of glutathione in inhalation and injectable forms. The recall covers products distributed nationwide and in several international locations, including the Bahamas, Colombia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and the West Indies, between November 21, 2011, and May 21, 2012.

The recall was initiated because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where these sterile products were prepared. This lack of assurance of sterility poses a risk to patients who use these injectable or inhalation medications.

Consumers and healthcare providers should stop using the affected products immediately. The specific prescription numbers associated with the recalled units are listed in the official recall documentation. Patients should contact their healthcare provider for alternative treatment options.

The recalled product

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 ML, 40 ML, 40 MLS, 50 ML, 58 MLS, 70 ML; GLUTATHIONE P.F. 50MG/ML (500MG/10ML) INJECTABLE 100 ML, 150 ML, 20 ML, 40 ML, 60…
Manufacturer: Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Category: Drug — Sterile Injectable/Inhalation
Hazard: microbial-contamination
fungal-growth
infection-risk
Affected units: 47

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 100 recalled by Franck's Lab Inc., d.b.a. Franck's Compounding Lab under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 100 products in this recall →

Same manufacturer · Franck's Lab Inc., d.b.a. Franck's Compounding Lab

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Same hazard · microbial contamination