Bulletin

Metoprolol Tablets

18 November 2009

Products Affected - Description

Metoprolol succinate extended release tablets, Ethex
100 mg, 100 unit-dose (NDC 58177-0368-11) - discontinued
100 mg, 100s (NDC 58177-0368-04) - discontinued
100 mg, 1000s (NDC 58177-0368-09) - discontinued
200 mg, 100s (NDC 58177-0358-04) - discontinued
200 mg, 1000s (NDC 58177-0358-09) - discontinued

Metoprolol succinate extended release tablets, Sandoz
25 mg, 100s (NDC 00185-0281-01)
25 mg, 1000s (NDC 00185-0281-10)
50 mg, 100s (NDC 00185-0282-01)
50 mg, 1000s (NDC 00185-0282-10)
100 mg, 100s (NDC 00185-0283-01)
100 mg, 1000s (NDC 00185-0283-10)
200 mg, 100s (NDC 00185-0284-01)
200 mg, 1000s (NDC 00185-0284-10)

Reason for the Shortage

In December 2008, KV Pharmaceuticals, which markets prescription medications through Ethex, voluntarily suspended shipment of all prescription tablet products. In early 2009, FDA filed an injunction against KV Pharmaceuticals preventing the company from manufacturing any products until all issues are resolved. Ethex has temporarily discontinued metoprolol extended-release tablets.
Sandoz has metoprolol extended release tablets on back order due to a product recall in September 2008.
Par’s metoprolol extended release tablets were in short supply due to increased demand.

Estimated Resupply Dates

Par has available metoprolol extended release 25 mg tablets 100 count (NDC 49884-0404-01) and 1000 count (NDC 49884-0404-10), 50 mg tablets 100 count (NDC 49884-0405-01) and 1000 count (NDC 49884-0405-10), 100 mg tablets 100 count (NDC 49884-0406-01) and 1000 count (NDC 49884-0406-10), and 200 mg tablets 100 count (NDC 49884-0407-01) and 1000 count (NDC 49884-0407-10).
Astra-Zeneca has available all Toprol XL presentations including 25 mg tablets 100 count (NDC 00186-1088-05), 25 mg tablets 100 count unit dose (NDC 00186-1088-39), 50 mg tablets 100 count (NDC 00186-1090-05), 50 mg tablets 100 count unit dose (NDC 00186-1090-39), 100 mg tablets (NDC 00186-1092-05), 100 mg tablets 100 count unit dose (NDC 00186-1092-39), and 200 mg tablets (NDC 00186-1094-05), and 200 mg tablets 100 count unit dose (NDC 00186-1094-05).
Watson has available all metoprolol extended release presentations including 25 mg tablets in 100 count (NDC 62037-0830-01) and 1000 count (NDC 62037-0830-10) and 50 mg tablets in 100 count (NDC 62037-0831-01) and 1000 count (NDC 62037-0831-10).
Sandoz has all of their products on back order and will not estimate a release date.

Safety

Dosing errors with metoprolol have been reported to the Institute for Safe Medication Practices (ISMP). Because of the recent shortage, many practitioners are switching patients from metoprolol extended-release products to metoprolol immediate-release tablets. Some of these patients are taking their metoprolol immediate-release tablets once daily instead of twice daily as required.

Related Shortages

Carvedilol Tablets— Resolved
Esmolol Injection— Resolved
Labetalol Injection— Resolved
Metoprolol Injection— Resolved
Propranolol Long-Acting Capsules— Resolved

Updated

November 18, 2009; October 8, 2009; September 1, 2009; August 5, 2009; August 4, 2009; July 22, 2009; July 2, 2009; June 9, 2009; May 7, 2009; April 22, 2009; April 6, 2009; March 23, 2009; March 13, 2009; February 18, 2009; January 26, 2009, University of Utah, Drug Information Service. Copyright 2009, University of Utah, Drug Information Service.

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