If you have further distributed the recalled product, to the wholesale or retail level, please notify any accounts or additional locations which may have received the recalled product from you. The affected diphenoxylate hydrochloride and atropine sulfate lots include the following lot numbers and expiration dates.
It works by stopping the growth of bacteria that can cause infections.Patients who have had a stem cell transplant should not stop taking azithromycin without first consulting with your health care professional. Product Recall: Azithromycin. The FDA Alert(s) below may be specifically about Z-Pak or relate to a group or class of drugs which include Z-Pak (azithromycin).MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Non-US country and region specific information is not available on this page. When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. Select one or more newsletters to continue.
Products were distributed nationwide to wholesalers/retailers from November 2016 through June 2017 in the United States.Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process.Patient safety is our first priority. FDA does not endorse either the product or the company.For Immediate Release – PEAPACK, NJ, November 16, 2017 - Greenstone LLC, a wholly owned subsidiary of Pfizer Inc., is voluntarily recalling multiple lots of diphenoxylate hydrochloride and atropine sulfate tablets, USP to the consumer level. The study reported an increase in cardiovascular deaths, and in the risk of death from any cause, in persons treated with a 5-day course of azithromycin (Zithromax) compared to persons treated with amoxicillin, ciprofloxacin, or no drug.
Greenstone Announces the Introduction of Mesalamine Delayed-Release Capsules. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. ET, Monday through Friday.Consumers with questions regarding this recall can contact Pfizer using the below information.Consumers should contact their healthcare provider if they have experienced any problems that may be related to taking or using this drug product.Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.This recall is being executed with the knowledge of the U.S. Food and Drug Administration. If a patient was to receive a sub potent tablet, symptoms may not be controlled.
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Doing so could be harmful without your health care professional’s direct supervision. Greenstone has notified wholesalers/retailers to arrange for return of any recalled product.Distributors or retailers with an existing inventory of the lots, which are being recalled, should stop use and distribution and quarantine immediately. Greenstone Announces the Introduction of Azithromycin Tablets. Greenstone LLC manufactures, markets and/or distributes more than 65 drugs in the United States. It is sold under the brand names Zithromax and Zmax and as generics by many different drug companies. Greenstone initiated this recall because product from these lots has the potential to be super potent or sub potent. Read More. Read More. June 24, 2019 ... June 3, 2019.
Serious adverse events such as coma and respiratory depression areimprobable.