Fagron is recalling all unexpired lots of its topical anesthesia that was distributed nationwide to hospitals, pharmacies and distributors after the FDA found possible bacterial contamination.
The analysis identified Bacillus fortis/Geobacillus toebii, Bacillus spp, and Bacillus circulans as contaminants in a component of the company's Lets Gel Kit Convenience Packs.
The non-sterile product increases the risk of infection for patients, the company said.
Fagron has not received any adverse reports related to the recall to date.
Hospitals, pharmacies and distributors should immediately discontinue use of the affected lots and quarantine the product.
Read the full news release here.