FDA Reports Nationwide Recall of Senna Syrup 8.8 mg/5 ml Because of Microbial Contamination
On January 12, 2022, the U.S. Food and Drug Administration (FDA) reported (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lohxa-llc-issues-voluntary-nationwide-recall-senna-syrup-88mg5ml-due-microbial-contamination) Lohxa’s voluntary recall of one lot of senna syrup 8.8 mg/5 ml unit-dose cups to the consumer level because of microbial contamination.
In the recall, Lohxa advised that use of the contaminated product by older adults, patients with a weakened immune system, or patients at a higher risk for developing life-threatening heart inflammation could result in serious or fatal infections. To date, Lohxa has not received any reports of adverse events related to the recall.
The product is used as a natural vegetable laxative for the relief of occasional constipation and is packaged into 5 ml unit-dose cups. The product was distributed into cases of 20 cartons, packaged with 24 units each, with the national drug code 50268-731-24. The affected lot number is AM1115S with an expiration date of 01/2023. The product was distributed to AvKare at the wholesale level, which may have further distributed it to clinics, hospitals, and healthcare providers.
FDA reported that Lohxa is notifying its distributors and arranging for the return of all recalled products. Patients that have the recalled product should discontinue use and return it to the place of purchase.
Patients with questions regarding the recall can contact Lohxa at 800-641-5564, Monday–Friday, from 9 am–5 pm ET, or at firstname.lastname@example.org (mailto:email@example.com).
Healthcare professionals and consumers should report any adverse reactions or quality problems (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm) they experienced using the product to MedWatch, FDA’s Safety Information and Adverse Event Reporting Program.