As with the previous recall of some 60 generic drug products, the products are being recalled because the generic products may have been manufactured under conditions that “did not sufficiently comply with current Good Manufacturing Practices,” according to a follow-up press release issued Wednesday by the FDA.

Some medicines on ETHEX’s earlier list of recalled products include Digitek, a common treatment for heart conditions, and Dextroamphetamine Sulfate, a medication generally prescribed for narcolepsy and attention deficit disorder with hyperactivity.

Both medications were recalled in 2008 after oversized tablets were discovered in some batches. Such defects may deliver higher than labeled doses of medication and can cause serious, life threatening conditions in patients who take them.

ETHEX says the expanded recall is to ensure that all defective products have been removed from the market.

A complete listing of recalled generic products can be viewed on ETHEX’s January 28 press release, ETHEX’s February 4 follow up press release, and Ther-Rx Corporation’s release.

Patients who have any of these medications in their possession are advised to continue taking them in accordance to their prescriptions as suddenly stopping them could put patients at risk. Patients also should contact their healthcare provider if they experience any problems or have questions about their prescriptions.

SOURCE: Digitek Recall › ETHEX issues update to earlier recall, prenatal vitamins added to list

Some of the products, such as Dextroamphetamine Sulfate generally prescribed for narcolepsy and attention deficit disorder with hyperactivity, fell under an earlier recall due to defects such as oversized tablets delivering higher than labeled doses of medication. The expanded recall is to ensure that all defective products have been removed from the market.

Oversized tablets also plagued U.S. generic pharmaceutical group Actavis Totowa LLC, which recalled batches of Digitek last April.  Digitek is commonly used in the treatment of various heart conditions.

ETHEX has recall notifications to wholesalers for several drugs and to pharmacy retailers for Hydromophone HCI and Metoprolol Succinate only. Hydromophone HCI is a analgesic drug from the opioid class drug often used as an alternative to morphine. Metoprolol Succinate is a medication used to treat several conditions related to the heart and blood vessels. A complete listing of medications recalled is available from the FDA.

Patients who have any of these medications in their possession are advised to continue taking them in accordance to their prescriptions, as suddenly stopping them could put patients at risk. Patients also should contact their health care provider if they experience any problems or have questions about their prescriptions.

Any wholesale or retail customer inquiries related to this action should be addressed to ETHEX Customer Service at 1-800-748-1472, faxed to ETHEX Customer Service at 314-646-3788, or e-mailed to customer-service@ethex.com. Representatives are available Monday through Friday, 8 am to 5 pm CST.

SOURCE: Digitek Recall › ETHEX expands voluntary recalls