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Ethex Corporation Product Recall
Audience: Pharmacists, Consumers
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.
Read the complete MedWatch 2009 Safety summary, including links to the firm's press release and two previous alerts, at:
http://www.fda.gov/medwatch/safety/2009/safety09.htm#Ethex
You are encouraged to report all serious adverse events and product quality problems for human medical products to MedWatch at: www.fda.gov/medwatch/report.htm.
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