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Toprol-XL FDA Alerts

The FDA Alert(s) below may be specifically about Toprol-XL or relate to a group or class of drugs which include Toprol-XL (metoprolol).

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for metoprolol

Ethex Corporation Product Recall

Jan 28, 2009

Audience: Pharmacists, Consumers

[Posted 01/27/2009] FDA notified pharmacists and consumers that ETHEX Corporation has expanded two previous 2008 recalls to include over 60 generic drug products recalled to wholesalers, and two generic drug products, Hydromorphone HCl and Metoprolol Succinate, recalled to retailer level. These generic products may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practices. Some of these products have had specific lots recalled earlier due to defects found, including oversized tablets delivering higher than labeled doses. These additional products are being removed to assure that no other defective products remain in the marketplace. Patients who may have these medicines in their possession should continue to take them in accordance with their prescriptions, as the risk of suddenly stopping needed medication may place patients at risk. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products, or to obtain replacement medications or prescriptions.

[January 28, 2009 - Press Release - Ethex]

Toprol-XL (metoprolol succinate)

Sep 26, 2005

Audience: All healthcare professionals

[UPDATE November 10, 2005] Letters from Novartis Pharmaceuticals Corporation added below
[UPDATE September 30, 2005] Letters from Ortho-McNeil Neurologics, Inc. added below

[Posted 09/26/2005] AstraZeneca and FDA notified healthcare professionals reports of medication dispensing or prescribing errors between Toprol-XL (metoprolol succinate) extended release tablets, indicated for the treatment of hypertension, long-term treatment of angina pectoris, and heart failure NYHA Class II or III, and Topamax (topiramate), a product of Ortho-McNeil Neurologics, Inc, indicated for the treatment of epilepsy and migraine prophylaxis. There have also been reports of medication errors involving confusion between Toprol-XL and Tegretol or Tegretol-XR (carbamazepine), products of Novartis Pharmaceuticals Corporation, indicated for the treatment of complex partial seizures, generalized tonic-clonic seizures, and trigeminal neuralgia. These reports include instances where Toprol-XL was incorrectly administered to patients instead of Topamax, Tegretol, or Tegretol-XR, and vice versa, some of them leading to adverse events.

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