Franck's Lab Recalls Sterile Lidocaine Drugs Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile lidocaine products distributed between November 2011 and May 2012 after FDA sampling 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 the presence of microorganisms and fungal growth in sterile injectable products presents a significant risk of serious injury or infection, 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 involves 434 units of various lidocaine HCL products, including sterile jelly, solution, and injectable forms in multiple concentrations and volumes.
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 of infection to patients using the products.
The affected products were distributed nationwide and to the Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and the West Indies. Consumers and healthcare providers should stop using the recalled products and contact their healthcare provider or the recalling firm for instructions on return or disposal.
The recalled product
- Product
- LIDOCAINE HCL (STERILE) 4% JELLY 120 ML 30 ML; LIDOCAINE HCL 4% SOLUTION 200 ML 300 ML 500 ML 600 ML; LIDOCAINE HCL 1% INJECTABLE 100 ML 1000 ML 1200 ML 1250 ML…
- Category
- Drug — Sterile Injectables
- Affected units
- 434
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 98 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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