Safety Report: AVpak Senna Syrup 5mL - recalled due to potential microbial contamination, USA

United States

Lohxa LLC is voluntarily recalling one lot of Senna Syrup 8.8mg/5mL, unit-dose cups to the consumer level. The product is being recalled due to microbial contamination. Use of contaminated product by the elderly, patients with a weakened immune system, or patients at a higher risk of developing life-threatening inflammation of the heart, could result in infections that could be life-threatening.

To date, Lohxa LLC has not received any reports of adverse events related to this 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 is distributed into cases of 20 cartons packaged with 24 units each, NDC: 50268-731-24. The affected Senna Syrup 8.8mg/5mL lot is AM1115S with expiration date of 01/2023. The product can be identified by the label attached.

Product was distributed to AvKare (Wholesaler) who may have further distributed this to clinics, hospitals, and healthcare providers. Outer carton labeling (see images) Unit-Dose Cups (see image) Lohxa LLC is notifying its distributors and customers by letter and is arranging for return of all recalled products. Consumers/distributors/retailers that have product which is being recalled should stop using the product and return it to place of purchase.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Company name: Lohxa LLC
Brand name: AVpak
Product recalled: Senna Syrup 5mL
Reason of the recall: Potential microbial contamination
FDA Recall date: January 12, 2022

Check the full recall details on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lohxa-llc-issues-voluntary-nationwide-recall-senna-syrup-88mg5ml-due-microbial-contamination

Source: FDA