The Food and Drug Administration (FDA) published an announcement from Mylan Pharmaceuticals, Inc., which did not specify the nature of the foreign substance, and emphasized that while exposure to it is “expected to be rare,” the company also did not want to rule out “the remote risk of infection.”
The FDA and Mylan also released instructions for wholesalers, retailers and consumers who believe they may have the lot in question.
The lot is a single batch of 0.5 mg alprazolam, the generic form of Xanax, which is packaged in a 500-count bottle. The batch was distributed in the United States between July and August of 2019, and has the following identification:
Alprazolam Tablets, USP C-IV 0.5 mg
Lot Number: 8082708
National Drug Code (NDC): 0378-4003-05
Expiration Date: September 2020
Yahoo Lifestyle attempted to ask Mylan what the foreign substance in question was, and was referred by a company spokesperson to the press statement issued by the FDA. No recall has been issued for Xanax or other batches of alprazolam.
Contact Your Doctor If You Experience Issues Related To The Drug
Mylan also noted that while no reports of “adverse effects” due to the batch have been issued, it also stated that consumers who experienced any problems related to the drug should contact their physician or healthcare provider. They can also report any problems to the FDA’s MedWatch Adverse Event Reporting program by calling 1-800-332-1088 or submitting a form online.
Distributors and customers have been informed by letter about the recall and according to the FDA, will arrange for pickup of all recalled products. Wholesalers and retailers were advised to examine their inventory for the batch in question and quarantine any that they might find; if a batch was distributed to retail level customers, they are advised to contact the regulated substance disposal company Stericycle at 1-888-843-0255.
Consumers should also contact Stericycle at the aforementioned number in order to receive a documentation package to return the medication.
Yahoo Lifestylenoted that the recall comes on the heel of drug maker Sanofi issuing a “precautionary” and “voluntary” recall of the heartburn medication Zantac in the United States and Canada. The FDA announced in September 2019 that low levels of a cancer-causing chemical were found in the product.