TOPIC: Senna Syrup 8.8 mg/5 mL by Lohxa: Recall - Due to Microbial Contamination
AUDIENCE: Patient, Consumer, Health Professional, Pharmacy
ISSUE: Lohxa is recalling one lot of Senna Syrup 8.8 mg/5 mL, unit-dose cups 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 has not received any reports of adverse events related to this recall.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: The product is used as a natural vegetable laxative for the relief of occasional constipation.
RECOMMENDATIONS:
Lohxa 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.
Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report online.
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.
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