ETHEX Issues Massive Recall of Generic DrugsJan 29, 2009 | Parker Waichman LLP
ETHEX Corp. is recalling scores of generic drugs that might be defective. The recall is part of a larger action taken by KV Pharmaceuticals - the parent of ETHEX Corp. - which we reported on earlier this week.
According to an ETHEX press release, the massive recall is necessary because the medications may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practices. Some of the medications have had specific lots recalled earlier due to defects found, including oversized tablets delivering higher than labeled doses. ETHEX said the additional products are being removed to assure that no other defective products remain in the marketplace.
The ETHEX recalls is taking place at both the retail and wholesale level. Drugs recalled at the retail level include:
- Hydromorphone HCl Tablets, 2mg (Lot #s 58177-620-04 & 620-11)
- Hydromorphone HCl Tablets, 4mg (Lot #s 58177-621-04 & 621-11)
- Hydromorphone HCl Tablets, 8mg (Lot #s 58177-449-04)
- Metoprolol Succinate ER Tablets, 50mg (Lot #s 58177-369-04, 369-09 & 369-11)
- Metoprolol Succinate ER Tablets, 100mg (Lot #s 58177-368-04, 368-09 & 368-11)
- Metoprolol Succinate ER Tablets, 25mg (Lot #s 58177-293-04, 293-09 & 293-11)
- Metoprolol Succinate ER Tablets, 200mg (Lot #s 58177-358-04, 358-09 & 358-11)
ETHEX said that 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. A complete list of the drugs recalled by ETHEX are available here.
Earlier this week, KV Pharmaceuticals suspended manufacturing and shipping of all of its products, including those made by its subsidiary, ETHEX. That announcement followed an inspection that began in December by the U.S. Food and Drug Administration of the company's operations and inventory.
ETHEX has also issued multiple recalls this year because of production problems related to the KV shutdown. In December, the drug maker recalled a single lot of Hydromorphone HCl 2 mg tablets because some of them may have been oversized. In November, the company initiated a nationwide voluntary recall of five generic drugs due to the potential for oversized drugs. Those medications included various lots and sizes of Propafenone HCl Tablets, Isosorbide Mononitrate Extended Release Tablets, Morphine Sulfate Extended Release Tablets, Morphine Sulfate Immediate Release Tablets and Dextroamphetamine Sulfate Tablets. That action followed an October recall of three lots of potentially oversized Dextroamphetamine Sulfate. And in June, ETHEX recalled several lots of 60 mg and 30 mg morphine extended release tablets that may have been oversized.