Drug Safety Alerts

Senna Syrup 8.8 mg/5 mL unit dose cups Consumer-Level Recall

1/11/2022

On January 11, 2022, Loxha issued a consumer-level recall of one lot of Senna Syrup 8.8 mg/5 mL unit dose cups, NDC # 50268-0731-24, manufactured by Lohxa, LLC and distributed by AvKARE. This recall was issued due to microbiological contamination. Use of contaminated product by either 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 life-threatening infections. Lohxa LLC has advised that as of the date of recall, it has not received any reports of adverse events related to this recall.

This could be a health hazard or safety risk to patients using product affected by this recall.

This recall affects lot number AM1115S exp. 01/2023. Loxha is advising consumers, distributors and retailers in possession of the product being recalled to stop using the product and return it to place of purchase.

CVS Caremark Response:

Please note: This product is not carried by the CVS Caremark® Mail Service Pharmacies.

For more information about this recall, please call AvKARE Customer Service at 1-931-908-2199. You may also call the United States Food and Drug Administration (FDA) at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit https://www.fda.gov.