Lohxa issued a voluntary recall of one lot of a laxative because of microbial contamination.
The Worcester, Massachusetts-based drug repackager is recalling one lot of Senna Syrup 8.8-mg/5-mL, unit-dose cups designated as lot AM1115S with an expiration date of Jan. 1, 2023. The product was distributed through the wholesaler AvKare and may have reached clinics, hospitals and healthcare providers.
The company said it hasn’t received any reports to date of adverse events related to the recall. Elderly patients with weakened immune systems or patients at greater risk of developing life-threatening inflammation of the heart are at greatest risk from contamination.
Senna Syrup is a natural vegetable laxative used to relieve occasional constipation. It is distributed in cases of 20 cartons containing 24 units each.
Back in 2019, the FDA slapped Lohxa with a warning letter for noting 12-month expiration dates on certain repackaged drugs without any data to support those dates. The warning impacted lots of repackaged unit dose drugs including pneumonia treatment atovaquone oral suspension.
At the time, the company said it had the data to support a six-month expiration date, but the regulatory agency said Lohxa had not made the information available.