Franck's Lab Recalls Sterile Human Drugs Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile human drugs distributed between November 2011 and May 2012 after FDA sampling found microorganisms and fungal growth in the preparation clean room.
What this means for you
Illness, injury, or structural failure has been reported. 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 a lack of assurance of sterility in sterile human drugs, which poses a significant risk of infection and potential hospitalization, meeting the criteria for a Severe rating.
Plain-English summary
Franck's Lab Inc., d.b.a. Franck's Compounding Lab, has initiated a recall of all sterile human drugs distributed between November 21, 2011, and May 21, 2012. The recall was triggered by FDA environmental sampling that revealed the presence of microorganisms and fungal growth in the clean room where these sterile products were prepared.
The affected products include Droptainer Sterile Plastic (2 x 7ml) 10 Bottle 4 Pk (2 Different Products). The recall covers units distributed nationwide as well as in the Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies. Specific prescription numbers associated with the recall are T0395419 and T0393096.
Consumers and healthcare providers should stop using the recalled products and contact their pharmacist or the recalling firm for instructions on how to return or dispose of the medication. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- DROPTAINER STERILE PLASTIC (2 X 7ML) 10 BOTTLE 4 PK (2 DIFFERENT PRODUCTS)
- Category
- Drug — Sterile Human Drugs
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Rx #'s: T0395419 T0393096
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.
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