Two subsidiaries of KV Pharmaceutical, ETHEX Corporation and Ther-Rx Corporation, have issued an update to an announcement issued just days earlier, expanding even more on a long list of generic drug products recalled at the wholesale or retail levels. This new release includes the nationwide recall at the wholesale level of prescription prenatal and iron supplements.
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.
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.