ETHEX Recall Goes To Retail Pharmacy Level For Hydromorphone HCl Tablets And Metoprolol Succinate ER Tablets, Only; All Other ETHEX Generics Recalled To Wholesale Level
(Posted by Tom Lamb at DrugInjuryWatch.com)
In late December 2008 KV Pharmaceutical announced another drug recall involving its subsidiary ETHEX Corporation, which covered "a single production lot of Hydromorphone HCl 2 mg tablets (Lot 90219, Exp: 3/2010; NDC 58177-0620-04), a pain management drug, following the report of an oversized tablet."
In that same December 23, 2008 press release, we learned that KV Pharmaceutical was voluntarily suspending all shipments of its approved tablet-form drugs" to all the drug company an opportunity to improve its "manufacturing and quality systems".
We ended our article about that 2008 ETHEX one-lot Hydromorphone recall in this manner: "Now we will wait to see if this Hydromorphone recall is expanded beyond the single lot identified initially by ETHEX."
About a month later we got our answer, which came in the form of a January 28, 2008 press release, "ETHEX Corporation Issues Nationwide Voluntary Recall of [All Its] Products".
This January 2008 press release from KV Pharmaceutical, the parent company of ETHEX, includes a list of the more than 60 generic drugs being recalled by ETHEX. Only two of these generic drug products, Hydromorphone HCl tablets and Metoprolol Succinate ER tablets, were recalled to the pharmacy, or retail, level. The recall of all other ETHEX drugs was limited to the wholesale level.
From a January 28 FDA MedWatch Email Alert about this all-pills, all-lots ETHEX recall:
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.
As some of you know, there were several recalls of ETHEX drugs in 2008:
- ETHEX Corporation Expands Its Voluntary June 2008 Recall Of Morphine Sulfate Extended Release Tablets
Related to the Metoprolol Succinate ER tablets aspect of this latest ETHEX recall, on January 30 the FDA issued this "Drug shortage" notice, "Metoprolol succinate extended release tablets".
We have heard from many patients affected by this shortage of Metoprolol ER pills -- the generic of Toprol-XL -- in the numerous Comments that have been submitted to these two articles we did previously concerning the earlier Metoprolol recall issued by Sandoz, a subsidiary of Novartis:
We would like to hear how your doctor and/or pharmacist is handling this latest recall by ETHEX, and the current Metoprolol pill shortage in particular.
P.S. For an update, see this February 3, 2009 drug company Press Release which has been posted on the FDA's web site:
We will continue to monitor this ETHEX 2009 drug recall and report significant developments. (2/4/09)