Virtus Pharmaceuticals Initiates Voluntary Recall of Some U.S. Hyoscyamine Tablets -Sept. 2016
IBS Impact has recently learned of a voluntary recall of some batches of some forms of hyoscyamine tablets distributed by Virtus Pharmaceuticals. Hyoscyamine (Levsin, Levbid and other various brand names) is an anticholernergic agent prescribed for some adults and children with IBS or related functional gastrointestinal disorders. As this is a generic medication, not all hyoscyamine comes from Virtus, but readers are advised to check.
The recall involves certain lots of sublingual tablets, oral disintegrating tablets and regular tablets in the 0.125 strength only. These lots have been distributed throughout the United States and the commonwealth of Puerto Rico since March 2016. According to the official FDA recall report, Virtus initiated this recall because some of the tablets contain either too little or too much hyoscyamine. A small portion of the affected lots also have incorrect expiration dates. There have been a few reports of various adverse symptoms from those lots that contained an unintended overdose. While the individuals required medical treatment, none of the reported situations appeared to be life threatening, and as far as is known, have resolved. Full details on the affected lot numbers and reported symptoms are in the link above. People with medication from these lots are advised to stop taking the medication and consult a doctor, especially if they have experienced any unusual symptoms or side effects. Contact information for both Virtus and the FDA is contained within the linked page.
IBS Impact encourages affected individuals to read the above links thoroughly and bring any questions or concerns to their own health care providers.